ABSTRACT
Omadacycline, a novel once‐daily aminomethylcycline antibiotic agent, demonstrates efficacy against prevalent pathogens responsible for community‐acquired pneumonia (CAP) in adults. However, the safety and efficacy of omadacycline in younger children have not yet been established. This case report presents a 4‐year‐old girl with a mixed infection of CAP who exhibited hypersensitivity to multiple antimicrobial agents (piperacillin‐tazobactam, ceftazidime, fosfomycin, meropenem, and levofloxacin), was treated with omadacycline followed by doxycycline, and underwent bronchoscopy with bronchoalveolar lavage. The child's condition improved, and no adverse reactions to omadacycline were observed. Potential adverse effects of omadacycline were evaluated, along with its utilization and dosage in children. Omadacycline has the potential to be a viable alternative anti‐infective agent for the treatment of pediatric CAP in the absence of other drug options and with adequate safety evaluation and monitoring.
Keywords: community‐acquired pneumonia (CAP), mixed infection, Mycoplasma pneumoniae pneumonia, omadacycline
Key Clinical Message
Omadacycline may serve as an alternative therapy for community‐acquired pneumonia (CAP) in children, particularly in cases involving multi‐drug‐resistant pathogens and multiple antibiotic allergies.
A short‐term intravenous course use appears to be safe with manageable gastrointestinal side effects, but dental risks and pediatric pharmacokinetic uncertainties require further investigation.
Abbreviations
- AAD
prevents antibiotic‐associated diarrhea
- ADE
adverse drug event
- CAP
community‐acquired pneumonia
- H. influenzae
Haemophilus influenzae
- HSRs
hypersensitivity reactions
- M. catarrhalis
Moraxella catarrhalis
- M. pneumoniae
Mycoplasma pneumoniae
- MedDRA
Medical Dictionary for Regulatory Activities
- PTs
preferred terms
- S. pneumoniae
Streptococcus pneumoniae
- SOCs
system organ classes
- tNGS
targeted next‐generation sequencing
1. Introduction
Community‐acquired pneumonia (CAP) is an acute infection of the lung parenchyma that is acquired outside of healthcare facilities and is the leading cause of mortality among children under 5 in developing countries [1]. Globally, bacterial pathogens such as Streptococcus pneumoniae ( S. pneumoniae ) and Mycoplasma pneumoniae ( M. pneumoniae ) contribute significantly [2]. A study in China from 2009 to 2020 found that S. pneumoniae and M. pneumoniae were the main causes of CAP and severe CAP in children under 5 [3]. The COVID‐19 pandemic restrictions delayed the re‐emergence of M. pneumoniae [4], with prevalent clones in China showing high macrolide resistance [5]. The choice of antibiotics is restricted due to increased resistance to macrolides, limited use of different antibiotics in children, and the risk of allergic reactions. Omadacycline, based on tetracycline, is as effective as moxifloxacin in treating adult community‐acquired bacterial pneumonia [6]. There are few reports on the use of omadacycline in children under 8 due to worries about its impact on tooth and bone growth. This case report describes a pediatric patient with multiple antimicrobial allergies who improved after treatment with omadacycline for CAP. The adverse effects of omadacycline were assessed, along with its utilization and dosage in children.
2. Case Presentation/Examination
2.1. Case History
A 4‐year‐old girl was hospitalized at Ezhou Central Hospital on February 14, 2024, with a fever of 38.6°C. Initially, the fever spiked up to four times per day, which then subsided to a low‐grade fever, accompanied by a cough with difficulty in expectorating sputum. No wheezing, abdominal pain, diarrhea, or vomiting was present. Chest CT revealed infectious infiltrates in the right lung (Figure 1A,B). Collected sputum culture identified Streptococcus pneumoniae resistant to clindamycin, erythromycin, and oxacillin, but susceptible to Levofloxacin, Penicillin, Vancomycin, Linezolid, and Trimethoprim/sulfamethoxazole. Sputum targeted next‐generation sequencing (tNGS) (Kindstar Globalgene Technology Inc.): M. pneumoniae 2 × 106 copy/mL, S. pneumoniae 1 × 104 copy/mL, Haemophilus influenzae ( H. influenzae ) 7 × 103 copy/mL, Moraxella catarrhalis ( M. catarrhalis ) 4 × 102 copy/mL. Oral azithromycin was administered for 3 days. Following the intravenous administration of various antibiotics (piperacillin‐tazobactam, ceftazidime, fosfomycin, meropenem), the patient developed generalized pruritic wheal‐like urticaria. The rash subsided after the discontinuation of the medications. On February 18, 2024, although the child had been afebrile for 3 days and the cough had slightly improved, she began experiencing frequent vomiting (4–5 episodes per day) and was unable to eat. For further diagnosis and treatment, the child was admitted to Tongji Hospital with pneumonia.
FIGURE 1.
Chest CT images of a child with community‐acquired pneumonia allergic to multiple antimicrobial agents. (A, B) Chest CT 4 days before admission revealed infectious lesions in the right lung. (C, D) Chest CT on hospital Day 5 showed uneven transmission of both lungs, nodular shadows, and patchy high‐density shadows in the lower lobe of the right lung. (E, F) Chest CT 1 month after discharge showed significant regression of the right lung.
2.1.1. Past History
The child had a tendency to develop rashes from new shoes, with a family history of rhinitis and urticaria. In June 2023, she was infected with M. pneumoniae and experienced “shivering and sweating” during the infusion of cefoperazone sulbactam. The patient's guardian denied the history of hepatitis B and tuberculosis.
2.2. Differential Diagnosis, Investigations and Treatment
Based on the patient's medical history and other relevant examination results, the patient was diagnosed with CAP caused by M. pneumoniae combined with S. pneumoniae , but other bacterial infections (such as H. influenzae and M. catarrhalis ) cannot be ruled out either. Since the fever improved within 3 days but the patient's condition worsened after repeated vomiting, and considering the presence of consolidation shadows and bronchial inflation signs on the lung imaging, aspiration pneumonia cannot be excluded.
2.2.1. Physical Examination
Temperature 37°C, pulse 102 bpm, breathing 26 bpm, height 100 cm, weight 13.5 kg, clear mind, general spirit, general nutrition, pharyngeal slight congestion, tonsil I degree enlargement, chest symmetry, bilateral lung breath sounds coarse, right lung breath sound low. Normal heart rhythm, no murmurs. Abdomen flat, soft, no hepatosplenomegaly or tenderness. Limb movement normal, no neurological signs.
2.2.2. Laboratory Examination
On February 19, 2024, a urine test showed 1+ ketone body; other items were normal; allergens (food) were normal; routine stool test was negative; sputum tests showed no abnormalities in bacterial smear, culture, drug sensitivity, fungal culture, and drug sensitivity. Positive ELISA for IgM antibodies against M. pneumoniae , negative for other 8 items ( Legionella pneumophila serogroup I, Coxiella burnetii , Chlamydia pneumoniae , adenovirus, respiratory syncytial virus, influenza A virus, influenza B virus, parainfluenza virus 1/2/3). Multiplex RT‐PCR with capillary electrophoresis detected Mycoplasma pneumoniae DNA, but not the other 12 respiratory pathogens (influenza A virus RNA, influenza B virus RNA, influenza A H1N1 virus RNA, influenza A H3N2 virus RNA, respiratory syncytial virus RNA, parainfluenza virus RNA, human metapneumovirus RNA, human rhinovirus RNA, human bocavirus DNA, Chlamydia DNA, coronavirus RNA, adenovirus DNA). On February 21, 2024, stool norovirus RNA was detected by PCR‐fluorescent probe method. Table 1 shows additional laboratory test results.
TABLE 1.
Laboratory test results at different time points for a child with community‐acquired pneumonia allergic to multiple antimicrobial agents.
| Laboratory test | Normal range | 3 days before admission, February 15, 2024 | First day of hospitalization, February 18, 2024 | 1 day before discharge, February 25, 2024 |
|---|---|---|---|---|
| Routine bloodwork | ||||
| WBC (×109/L) | 4.4–11.9 | 7.12 | 6.98 | 5.53 |
| Neutrophil (×109/L) | 1.2–7.0 | 4.25 | 5.01 | 3.92 |
| Lymphocytes (×109/L) | 1.8–6.3 | 2.29 | 1.52 | 1.10 |
| Inflammatory index | ||||
| Hs‐CRP (mg/L) | < 5 | 17 | 3.72 | / |
| Procalcitonin (ng/mL) | < 0.1 | 0.16 | < 0.1 | / |
| Biochemical indexes | ||||
| ALT (U/L) | 7–40 | 12 | 12 | 8 |
| AST (U/L) | 13–35 | 37 | 40 | 49 |
| CK (U/L) | 26–140 | 103 | 76 | / |
| LDH (U/L) | 120–250 | 326 | 362 | 495 |
| Coagulation function | ||||
| FIB(g/L) | 1.8–3.5 | 3.85 | 3.81 | / |
| D‐dimer (mg/L) | < 0.5 | 0.53 | 0.99 | / |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine kinase; FIB, Fibrinogen; Hs‐CRP, High‐sensitivity C‐reactive protein; LDH, lactate dehydrogenase; WBC, white blood cell.
On February 18, 2024, the child was given levofloxacin intravenously, but had to stop immediately because of red hives and itching all over the body. On February 19, 2024, the treatment was switched to omadacycline, with an initial dose of 4 mg/kg given intravenously over 60 min, followed by a daily maintenance dose of 2 mg/kg given intravenously over 30 min. The next day, the child did not have nausea and vomiting, but had 7 episodes of yellow loose diarrhea. Montmorillonite powder was used to prevent diarrhea, Saccharomyces boulardii Sachets were used to regulate intestinal flora, and oral rehydration salt was used to supplement electrolytes. By day 3 of omadacycline treatment, the patient's cough improved, with no fever. By day 4, chest CT showed uneven transmission of both lungs, nodular shadows, and patchy high‐density shadows in the lower lobe of the right lung (Figure 1C,D). After 1 week of omadacycline treatment, the child was given sequential anti‐infection treatment with doxycycline (25 mg, oral, q12h) for 1 week. Due to persistent moist rales in the lungs and extensive consolidation on chest CT, bronchoscopy and alveolar lavage were performed on February 27, 2024, and the bronchial mucosa of the right lower lobe exhibited hyperemia and swelling, with a moderate amount of white mucus seen in the lumen of the anterior basal segment of the lower lobe. After negative pressure suction and lavage, there were many white foamy secretions in the other segments of the bronchial cavity, and no obvious foreign bodies, new organisms, cheese, or granulation were observed (Figure 2A–H). There were no abnormalities in the bacterial smear of bronchoalveolar lavage fluid, sputum culture and drug susceptibility, fungal culture, and drug susceptibility.
FIGURE 2.
Bronchoscopy findings for a child with community‐acquired pneumonia (A–H) Bronchoscopy shows bronchial mucosa of the lower lobe of the right lung was hyperemia and swelling, and a moderate amount of white mucus plug was seen in the bronchial lumen of the anterior basal segment of the lower lobe.
2.3. Outcome and Follow‐Up
On February 28, 2024, the patient's clinical symptoms had improved and were discharged in a stable condition. On March 31, 2024, a follow‐up chest CT examination showed significant regression of the right lung (Figure 1E,F), and the patient's general condition was satisfactory.
3. Discussion
3.1. Diagnosis of Etiology
Due to the age‐dependent variability and potential nonspecificity of symptoms in young children, the clinical diagnosis of CAP can be challenging. Therefore, timely and accurate identification of the causative pathogen is crucial for initiating targeted and effective antimicrobial therapy [7]. The NGS technology is revolutionizing clinical microbiology diagnostics by directly sequencing samples to improve detection of microorganisms of interest, especially in microorganisms that lack sensitivity or are not available by conventional methods [8]. The tNGS detection revealed a high copy number of M. pneumoniae and S. pneumoniae in the sputum of the child, along with elevated copy numbers of H. influenzae and M. catarrhalis exceeding 100, confirming the diagnosis alongside other tests.
The stool test of the child patient was positive for norovirus, which might be the cause of the vomiting that occurred 3 days after a temporary improvement. Frequent vomiting poses a risk of aspiration. In addition, the CT images of the child showed consolidation shadows on the right side and air bronchogram signs. Considering that aspiration pneumonia is more common in the right lower lobe and is related to the coarse, steep, and straight structure of the right bronchus, it cannot be ruled out that the child has developed aspiration pneumonia. Aspiration pneumonia is difficult to distinguish from other bacterial pneumonias based on clinical features. In community‐acquired cases, the main isolates are S. pneumoniae , Staphylococcus aureus , H. influenzae , and Enterobacteriaceae. For most patients with community‐acquired cases, mpicillin–sulbactam, a carbapenem (ertapenem), or a fluo roquinolone (levofloxacin or moxifloxacin) is effective [9].
Mycoplasma pneumoniae is a small, slow‐growing organism without a cell wall, making it naturally resistant to penicillin and β‐lactam antibiotics [4], macrolides, fluoroquinolones, and tetracyclines are commonly used in treating M. pneumoniae pneumonia, but there is high resistance to macrolides in China [5].
Streptococcus pneumoniae , H. influenzae , and M. catarrhalis are commensal bacteria of the human nasopharynx, which can cause various respiratory tract diseases through dissemination to distant sites in the body and are commonly detected concurrently in infected tissues [10, 11]. In previously healthy children under 5 years of age, high‐dose intravenous amoxicillin is the preferred treatment for these pathogens. Alternatives for children with penicillin allergies include clindamycin, azithromycin, clarithromycin, and levofloxacin [12]. The efficacy of these antimicrobials is declining due to the increasing resistance in S. pneumoniae [13]. In China, over 90% of pediatric S. pneumoniae strains have shown resistance to erythromycin, clindamycin, and tetracycline [14]. Furthermore, multiple studies have indicated a significantly higher macrolide resistance rate in pediatric S. pneumoniae infections in China compared to Western countries [15, 16, 17]. Additionally, the child's strain of S. pneumoniae was resistant to erythromycin, so azithromycin was not continued after admission.
3.2. Selection of Antimicrobial Agents
The child's hypersensitivity to multiple antibiotics (piperacillin‐tazobactam, ceftazidime, fosfomycin, and meropenem) and the pathogen resistance limited treatment options, so alternative antibiotic options for mixed infections were only fluoroquinolones and new tetracyclines. Considering the child's vomiting with difficulty in taking oral medication, levofloxacin was initially given intravenously. While fluoroquinolones are not typically the first choice for treating CAP in children due to potential joint and cartilage damage in young animals [18, 19, 20], they can be used safely when necessary [21]. However, the child also experienced a rash following levofloxacin injection. Ultimately, omadacycline was chosen due to the limited efficacy of doxycycline and minocycline against the identified S. pneumoniae strain and given the background of the children being allergic to multiple antibiotics. We explained in detail the potential risks of the off‐label use of omadacycline in children, such as the theoretical possibility of causing tooth staining and affecting cartilage development, and signed an informed consent form with the family of the child. Omadacycline demonstrates favorable in vitro activity against M. pneumoniae (including macrolide‐resistant strains), S. pneumoniae (including penicillin‐resistant and tetracycline‐resistant strains), and H. influenzae , while overcoming traditional tetracyclines' resistance mechanisms [22]. Nonetheless, tetracyclines are usually not recommended for children under 8 due to potential tooth damage risks [23], but a retrospective cohort study found no evidence of this with short‐term doxycycline before age 8 [24]. Multiple guidelines also indicate that available data do not associate staining of permanent teeth with doxycycline, in contrast to traditional tetracyclines, and recommend that the course of treatment should not exceed 21 days for children under 8 [25, 26]. Fortunately, the patient did not experience an acute and delayed allergic reaction to omadacycline. Historically, allergy to fluoroquinolones and tetracyclines has been reported less frequently compared with β‐lactam antibiotics. Fluoroquinolone‐induced anaphylaxis involves both IgE and non‐IgE mechanisms; immediate hypersensitivity reactions (HSRs) are more common than delayed reactions. For tetracyclines, cutaneous reactions of non‐IgE‐mediated delayed HSRs are the most common [27]. These factors, including the slow drug injection, may have contributed to the lack of allergic reactions, supporting the safety of omadacycline in children.
3.3. Pediatric Doses of Omadacycline
Two dose‐conversion methods were used to estimate the dose of omadacycline: based on the child's weight (standard adult height 175 cm, weight 70 kg), with an initial dose of 38.6 mg and a maintenance dose of 19.3 mg, according to the child's BSA using the Mosteller formula: BSA (m2) = [(height [cm] × weight [kg])/3600]1/2 [28], resulting in an initial dose of 66.4 mg and a maintenance dose of 33.2 mg. Considering the child's allergic constitution, a compromise dosage of 50.0 mg initially and 25.0 mg for maintenance was chosen. Omadacycline exhibits sufficient bioavailability to support both oral and intravenous administration, as well as low plasma protein binding, adequate pulmonary exposure [29], and a long half‐life for once‐daily dosing in adults [30, 31]. However, determining the appropriate dose and frequency for children is difficult due to differences in physiology and biochemistry. Given the pivotal role of drug clearance in dosage determination, various methodologies such as allometric models, physiologically based pharmacokinetic models, and population‐based pharmacometric models have been employed to forecast drug clearance in children, but each has limitations [32]. Real‐world pharmacokinetic and pharmacodynamic data of omadacycline in pediatric patients are essential to ensure both safety and efficacy.
Although the child's symptoms improved after medication, moist rales were still present in the lungs and the chest CT showed a large range of consolidation, which was difficult to absorb by drug therapy alone, leading to bronchoscopy and alveolar lavage. Sequential treatment with doxycycline was given for 1 week due to the unavailability of omadacycline oral formulations and the prolonged clearance period of M. pneumoniae .
3.4. Assessment of Adverse Reactions
Side effects are also a concern, and data on adverse drug event (ADE) reports for omadacycline were extracted from the World Health Organization database (WHO‐VigiBase, https://www.vigiaccess.org/) until March 31, 2024. These reports were only from the Americas and included participants aged 12 and older; we categorized them by 20 system organ classes (SOCs) and preferred terms (PTs) directly related to disease symptoms in the Medical Dictionary for Regulatory Activities (MedDRA) Adverse Drug Event Terminology set. The top three SOCs were gastrointestinal diseases, nervous system diseases, and skin and subcutaneous tissue diseases; the three most common PTs were nausea, vomiting, and diarrhea. Figure 3 illustrates the specifics of omadacycline in WHO‐VigiAccess; the raw data can be found in the Data S1. To mitigate gastrointestinal side effects and prevent antibiotic‐associated diarrhea (AAD), along with the detection of norovirus in the child's stool, montmorillonite powder and saccharomyces boulardii sachets were promptly administered. Given the child's history of allergic and frequent respiratory infections, probiotic supplementation can reduce the occurrence of respiratory infections, duration of cough and fever, as well as duration of antibiotic usage [33]. In this case, no adverse events were found, which to some extent confirms the relative safety of omadacycline in younger children.
FIGURE 3.
(A) Signal strength of reports of omadacycline at the System Organ Class (SOC) level in WHO‐VigiAccess. (B) Signal strength of reports of omadacycline at the Preferred Term (PT) level in WHO‐VigiAccess.
4. Limitations and Future Research
Although this case report provides valuable insights into the potential use of omadacycline in young children, there are several limitations. First, as a single case report, the study lacked a control group, blinding, or randomization, and the level of evidence was low. Second, the child was treated with a variety of antibiotics and underwent bronchoscopy and alveolar lavage, so it was impossible to accurately distinguish the contribution of omadacycline or bronchoscopy in the improvement of the disease. Third, this case report describes a temporal association (improvement with medication) but cannot prove causality.
In order to promote the application of omadacycline in the pediatric field, a rigorously designed prospective clinical study is needed to evaluate the safety and efficacy of omadacycline in children with CAP. The second is to study the pharmacokinetics of omadacycline in different age groups of children to determine the accurate dosing regimen; third, long‐term follow‐up studies are needed, with special attention to potential adverse effects such as dental pigmentation and bone development.
5. Conclusions
There is an appropriate highlight of omadacycline's potential but would benefit from reiterating the need for formal clinical trials in children to ensure safety and efficacy. Especially, the results of rigorous randomized controlled trials are essential to elucidate the causal relationship between novel tetracycline and dental staining. At the same time, the potential adverse reactions of omadacycline must also be considered, including newly discovered effects such as blurred vision reported in WHO‐VigiBase. Overall, omadacycline has the potential to be a viable alternative anti‐infective agent for the treatment of pediatric CAP in the absence of other drug options and with adequate safety evaluation and monitoring.
Author Contributions
Ziqi Xu: writing – original draft, writing – review and editing. Wen Pan: methodology. Hui Lei: methodology. Chen Dong: methodology. Biao Zou: methodology. Sainan Shu: project administration. Wenting Zhang: conceptualization.
Funding
The authors have nothing to report.
Ethics Statement
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Medical Ethics Committee of Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology. Written informed consent was obtained from all participants and the parents of the child.
Consent
Written informed consent for publication of their clinical details and clinical images was obtained from the parent's relative of the patient.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: ccr371625‐sup‐0001‐Supinfo.xlsx.
Acknowledgments
The authors have nothing to report.
Xu Z., Pan W., Lei H., et al., “Case Report: Omadacycline in the Treatment of Community‐Acquired Pneumonia in a Child With Multiple Antimicrobial Allergies,” Clinical Case Reports 13, no. 12 (2025): e71625, 10.1002/ccr3.71625.
Sainan Shu and Wenting Zhang contributed equally to this work.
Contributor Information
Sainan Shu, Email: shusainan@163.com.
Wenting Zhang, Email: wenting@hust.edu.cn.
Data Availability Statement
The datasets about ADE reports for omadacycline generated and analyzed during the current study are available in the [the WHO global database of reported potential side effects of medicinal products] repository, [https://www.vigiaccess.org/]. The other datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: ccr371625‐sup‐0001‐Supinfo.xlsx.
Data Availability Statement
The datasets about ADE reports for omadacycline generated and analyzed during the current study are available in the [the WHO global database of reported potential side effects of medicinal products] repository, [https://www.vigiaccess.org/]. The other datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.