Abstract
Objective
To evaluate the effectiveness of a simple sticker reminder in increasing intravenous-to-oral (IV-to-PO) fluoroquinolone (FQ) conversion rates.
Design
Single-center, cluster-randomized controlled trial.
Setting
Forty-five general wards at Siriraj Hospital, Bangkok, Thailand, from July 2020 through December 2024.
Patients
Hospitalized adult patients receiving intravenous fluoroquinolones who met predefined IV-to-PO conversion criteria.
Methods
Wards were randomized 1:1 to either a sticker reminder intervention or standard care. In the intervention group, a reminder sticker was placed on the vital signs sheet of eligible patients. The primary outcome was the proportion of IV-to-PO conversion in the intention-to-treat (ITT) and modified intention-to-treat (mITT) populations.
Results
A total of 168 patients were enrolled (85 intervention, 83 control). In the ITT population, the IV-to-PO conversion rate was 58.8% in the intervention group versus 42.2% in the control group (p-value = 0.03). In the mITT population (patients meeting all conversion criteria), the intervention group had a significantly higher conversion rate (69.0% vs. 48.5%; p-value = 0.01). No significant differences were observed in clinical cure rates, in-hospital mortality, length of stay, duration of either IV FQ or PO FQ therapy.
Conclusion
A sticker reminder intervention effectively increases IV-to-PO FQ conversion among eligible patients without compromising clinical safety. Future large-scale and qualitative studies are needed to further validate these benefits and explore prescriber hesitation.
Trial registration
ClinicalTrials.gov NCT07361185 (retrospectively registered on 22 January 2026).
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1186/s12879-026-13937-9.
Keywords: Antibiotic, Antimicrobial stewardship, Fluoroquinolone
Background
The World Health Organization promotes rational antimicrobial use and antimicrobial stewardship programs (ASP) to improve clinical outcomes, reduce resistance, and lower hospital expenditures [1]. ASP focuses on optimizing choice, dose, duration, and administration route of antimicrobial agents [2]. Early transitioning from intravenous to oral (IV-to-PO) therapy is a core strategy of ASP. Meta-analyses have demonstrated that IV-to-PO conversion reduces the duration of intravenous antibiotic therapy and reduce length of hospital stay without compromising clinical outcomes [3]. These benefits have been demonstrated in both non–life-threatening infections, such as bone and joint infections [4] and urinary tract infections [5], and life-threatening conditions, including gram-negative bacteremia [6, 7], Staphylococcus aureus bacteremia [8], and infective endocarditis [9].
Furthermore, the oral administration is less labor intensive for the nursing staff, and less economic burden due to additional costs of IV administration, such as cost of diluents, equipment for administration, needles, syringes, and nursing time [10]. Several obstacles of IV-to-PO conversion have been reported such as insufficient knowledge among prescribers, limited availability of effective oral antimicrobials with high bioavailability, physician reluctance, and concerns related to patients with multiple comorbidities [11, 12]. Previous studies conducted in Malaysia and Ireland showed that a simple intervention such as sticker reminder could promote the IV-to-PO conversion [13, 14].
In addition, the choice of route depends on antimicrobial pharmacokinetics and pharmacodynamic (PK/PD) properties, especially oral bioavailability comparable to intravenous formulations [15]. Several oral antimicrobials have high bioavailability (> 75%), including metronidazole, clindamycin, trimethoprim/sulfamethoxazole, linezolid, and fluoroquinolones [16]. Among these agents, fluoroquinolones (ciprofloxacin, levofloxacin, and moxifloxacin) are especially suitable for IV-to-PO conversion because of their favorable PK/PD properties, high oral bioavailability, broad antimicrobial spectrum, reliable efficacy, and good tolerability [16]. However, IV-to-PO conversion of fluoroquinolones should be undertaken with caution because of the potential for adverse drug reactions and drug–drug interactions. In particular, cation-containing products may significantly impair the oral absorption of fluoroquinolones [16].
Based on a pilot study conducted in 10 general medicine wards at Siriraj Hospital between April and September 2019, approximately 30% of patients receiving intravenous fluoroquinolone (FQ) therapy were transitioned to oral FQ therapy after meeting IV-to-PO conversion criteria. However, the rate of IV-to-PO conversion was lower in departments outside internal medicine. Based on these findings, we conducted a cluster-randomized controlled trial to evaluate the impact of a sticker reminder intervention on promoting IV-to-PO conversion of FQ therapy.
Material & methods
Study design and setting
We conducted a cluster-randomized controlled trial in forty-five general wards of Siriraj Hospital from July 1, 2020, to December 31, 2024. Siriraj Hospital is a 2,300-bed university-affiliated tertiary care center located in Bangkok, Thailand.
The study protocol was approved by the Institutional Review Board (IRB) of the Faculty of Medicine Siriraj Hospital, Mahidol University (COA #549/2020). A waiver of informed consent was granted for patients in the control group. For the intervention group, initial consent was obtained via telephone, followed by the completion of written informed consent prior to hospital discharge. The study was conducted in accordance with the principles of the Declaration of Helsinki. The study also adhered to the CONSORT statement, as detailed in Online Supplementary File 1. The clinical trial was retrospectively registered (NCT07361185) on 22 January 2026. The intervention was conducted as part of a quality improvement initiative and resident training project; therefore, the clinical trial was registered retrospectively. Nevertheless, all outcomes of interest were predefined prior to study commencement.
Participants and inclusion criteria
We included hospitalized adult patients (aged ≥ 18 years) diagnosed with any infection who had received at least one dose of intravenous FQs (ciprofloxacin, levofloxacin, or moxifloxacin). Patients were excluded if they: (1) were unable to tolerate oral medications (e.g., due to severe nausea/vomiting, malabsorption, active gastrointestinal bleeding, or severe diarrhea); (2) were in an immunodeficiency state (e.g., neutropenia [absolute neutrophil count ≤ 500 cells/mm3], symptomatic HIV/AIDS, history of bone marrow or organ transplantation, leukemia, or current use of immunosuppressive agents); or (3) had severe infections requiring exclusive intravenous antimicrobial therapy (e.g., infective endocarditis, meningitis, encephalitis, brain abscess, or prosthetic device infections).
Randomization
Forty-five general wards were randomized to either the control group (standard care) or the intervention group (sticker reminder). Randomization was performed using a computer-generated 1:1 allocation scheme with allocation concealment.
Intervention
Patients in the intervention group underwent daily bedside evaluations by an investigator. Once the predefined IV-to-PO conversion criteria were fulfilled, a reminder sticker was applied to the patient’s vital signs sheet, and the completed IV-to-PO criteria checklist was placed in the participant’s medical record within 24 h. The detailed IV-to-PO criteria checklist with a reference is available in the online supplementary file 2. The checklist included clinical stability, improving infection signs, ability to tolerate oral intake, absence of gastrointestinal absorption problems or immunocompromising conditions, and availability of an appropriate oral antimicrobial agent. The final decision to transition from intravenous to oral fluoroquinolone therapy remained at the discretion of the attending physician. Patients in the control group received standard care, where intravenous antibiotics were switched or discontinued at the discretion of the attending physician without external reminders.
Data collection
We collected sociodemographic characteristics (including age, sex, comorbidities, occupation, and health coverage), clinical data (e.g., infection type and site, vital signs), microbiological findings, details of antimicrobial therapy, and treatment outcomes. All data were collected retrospectively through chart review after patient discharge and recorded in standardized case report forms. Patient identifiers were removed prior to data entry to ensure anonymity.
Outcome assessment
The primary outcome was the proportion of IV-to-PO FQ conversion among the intention-to-treat (ITT) population (all participants) and the modified intention-to-treat (mITT) population (all participants who met the predefined criteria for conversion). Secondary outcomes included the clinical cure rate at the completion of antimicrobial therapy, in-hospital mortality, length of hospital stay (LOS), and the respective durations of intravenous and oral FQ therapy.
Sample size calculation
Based on retrospective data from 10 general wards at Siriraj Hospital (April–September 2019), 30% who receiving intravenous FQs were converted to oral therapy. We hypothesized that the intervention would increase the conversion rate to 50%. Assuming a two-sided alpha of 0.05 and 80% power, a sample size of 93 patients per group (186 total) was required to detect this difference. Additionally, based on parameters reported by Beyene et al. (mean IV duration: 8.64 ± 2.70 days; mean LOS: 13.45 ± 5.48 days), we estimated that detecting a 2-day reduction in IV therapy and a 5-day reduction in LOS would require 23 and 18 patients per group, respectively. To account for the cluster randomization design, the sample size was adjusted using a design effect calculated from the intra-cluster correlation coefficient of previous FQ prescribing data at Siriraj Hospital. To achieve all primary and secondary outcomes and account for an expected 10% dropout rate, a minimum of five patients per cluster was required. The final target sample size was determined to be 225 patients across at least 45 clusters (wards).
Statistical analysis
Descriptive statistics are presented as frequencies and percentages for baseline characteristics, clinical manifestations, and other categorical variables. Continuous variables are expressed as means ± SD or medians (range), as appropriate. Primary and secondary outcomes were compared between groups using the Chi-square test or Fisher’s exact test for categorical data, and the unpaired t-test or Mann-Whitney U test for continuous data. An intention-to-treat analysis was performed, with clustering effects accounted for by including cluster as a variable in the model. All statistical analyses were conducted using Stata version 14.0 (Stata Corp, College Station, TX, USA). A two-sided p-value ≤ 0.05 was considered statistically significant.
Results
Between July 1, 2020, and December 31, 2024, a total of 168 patients were enrolled: 85 in the intervention group and 83 in the control group. The number of participants per cluster varied from 0 to 11 in the intervention group and from 0 to 7 in the control group. The study was terminated early after reaching approximately 75% of the target sample size due to slow recruitment. Table 1 shows baseline characteristics of patients in the intervention group and control group. Figure 1 shows the study flow chart. Of the total 168 patients, approximately 50% were male. The mean (± SD) age was 66.41 ± 14.65 years in the intervention group and 66.83 ± 14.89 years in the control group (p-value = 0.85). Previous hospitalization was slightly more frequent among the intervention group (28.6% vs. 14.5%; p-value = 0.02).
Table 1.
Baseline characteristics of patients in the intervention group and control group
| Baseline characteristics | Intervention N = 85 (%) |
Control N = 83 (%) |
p-value |
|---|---|---|---|
| Male gender | 54 (63.5) | 43 (51.8) | 0.12 |
| Mean Age ± SD | 66.41 ± 14.65 | 66.83 ± 14.89 | 0.85 |
| Department | |||
| Internal medicine | 51 (60.7) | 39 (48.2) | 0.24 |
| Surgery | 23 (27.4) | 27 (33.3) | |
| Other | 10 (11.9) | 15 (18.5) | |
| Previous hospitalization | 24 (28.6) | 12 (14.5) | 0.02 |
| Underlying disease | |||
| Hypertension | 65 (76.5) | 57 (68.7) | 0.26 |
| Diabetes mellitus | 31 (36.5) | 28 (33.7) | 0.71 |
| Chronic kidney disease | 21 (24.7) | 19 (22.9) | 0.78 |
| Cerebrovascular disease | 14 (16.5) | 16 (19.3) | 0.64 |
| Cardiovascular disease | 13 (15.3) | 13 (15.7) | 0.95 |
| Chronic respiratory disease | 12 (14.1) | 7 (8.4) | 0.25 |
| Solid malignancy | 11 (12.9) | 11 (13.3) | 1.00 |
| Chronic liver disease | 5 (5.9) | 3 (3.6) | 0.49 |
| Hematologic disease | 5(5.9) | 4 (4.8) | 1.00 |
| Hematologic malignancy | 5 (5.9) | 3 (3.6) | 0.72 |
| Previous organ transplantation | 1 (1.2) | 1 (1.2) | 1.00 |
| Asymptomatic HIV infection | 4 (7.7) | 5 (6.0) | 0.75 |
| Type of infection | |||
| Community acquired infection | 66 (77.7) | 59 (71.1) | 0.33 |
| Hospital-acquired infection | 18 (21.2) | 21 (25.3) | 0.53 |
| Unknown | 1 (1.2) | 3 (3.6) | 0.37 |
| Site of infection | |||
| Lower respiratory infection | 25 (29.4) | 23 (27.7) | 0.81 |
| Urinary tract infection | 21 (24.7) | 29 (34.9) | 0.15 |
| Soft tissue infection | 16 (18.8) | 19 (22.9) | 0.52 |
| Gastrointestinal infection | 15 (17.7) | 13 (15.7) | 0.73 |
| Blood stream infection | 7 (8.2) | 1 (1.2) | 0.06 |
| Central venous catheter | 2 (2.4) | 1 (1.2) | 1.00 |
| Clinical and laboratory parameters | |||
| Systolic blood pressure (mmHg) | 134.88 ± 25.45 | 129.54 ± 23.57 | 0.16 |
| Diastolic blood pressure (mmHg) | 74.65 ± 13.87 | 73.31 ± 12.76 | 0.52 |
| Body temperature (Celsius) | 37.70 ± 0.89 | 37.8 ± 0.77 | 0.68 |
| Heart rate (per minute) | 93.36 ± 19.65 | 93.58 ± 15.15 | 0.94 |
| Respiratory rate (per minute) | 20.35 ± 1.93 | 20.65 ± 2.52 | 0.54 |
| White blood cell count (cell/mm3) | 13358.01 ± 13488.66 | 11950.45 ± 5093.00 | 0.39 |
| % Neutrophil | 77.17 ± 12.38 | 77.17 ± 11.25 | 0.61 |
| Serum creatinine (mg/dl) | 1.62 ± 2.08 | 1.47 ± 1.32 | 0.58 |
| Causative pathogen | |||
| Pseudomonas aeruginosa | 16 (19.3) | 15 (19.2) | 0.57 |
| Klebsiella pneumoniae | 10 (12.1) | 5 (6.4) | |
| Escherichia coli | 4 (4.8) | 7 (9.0) | |
| Staphylococcus aureus | 6 (7.2) | 5 (6.4) | |
| Acinetobacter baumannii | 2 (2.4) | 2 (2.6) | |
| Other Gram-negative bacteria | 12 (14.5) | 5 (6.4) | |
| Other Gram-positive bacteria | 2 (2.4) | 2 (2.6) | |
| Unknown pathogen | 31 (37.4) | 36 (46.2) | |
| Met all criteria for IV-to-PO conversion | 71 (83.5) | 68 (81.9) | 0.78 |
Fig. 1.
Study flow chart
Approximately 80% of patients in both intervention and control groups had community-acquired infections (77.7% vs. 71.1%; p-value = 0.33). The three most common comorbidities were hypertension (76.5% vs. 68.7%; p-value = 0.26), diabetes mellitus (36.5% vs. 33.7%; p-value = 0.71), and chronic kidney disease (29.4% vs. 27.7%; p-value = 0.81). The leading sites of infection were the lower respiratory tract (39.1% vs. 32.3%; p-value = 0.42), urinary tract (24.7% vs. 34.9%; p-value = 0.15), and skin and soft tissue (18.8% vs. 22.9%; p-value = 0.52).
The distribution of causative pathogens was similar between both groups (p-value =.0.38). The three most frequent pathogens (intervention vs. control) were Pseudomonas aeruginosa (14.1% vs. 16.9%), Klebsiella pneumoniae (15.6% vs. 4.6%), and Escherichia coli (3.1% vs. 7.7%). A similar proportion of patients in the intervention and control groups met all predefined IV-to-PO conversion criteria (83.5% vs. 81.9%; p-value = 0.78).
Outcomes of interest
Primary and secondary outcomes are summarized in Table 2. In the ITT population, the proportion of IV-to-PO conversion in the intervention group was significantly higher than in the control group (58.8% vs. 42.2%; p-value = 0.03). However, there was no statistically significant differences between the intervention and control groups across any secondary outcomes, including the clinical cure rate (95.3% vs. 90.4%; p-value = 0.22), in-hospital mortality (4.7% vs. 9.6%; p-value = 0.25), mean length of hospital stay (11.04 ± 8.30 vs. 13.99 ± 17.50 days; p-value = 0.16), mean duration of intravenous FQ therapy (6.02.± 4.56 vs. 7.91 ± 10.78 days; p-value = 0.14), and mean duration of oral FQ therapy (5.65 ± 6.78 vs. 5.48 ± 4.81 days; p-value = 0.85).
Table 2.
Primary and secondary outcomes of interest*
| Parameters | Intention to treat population | Modified intention to treat population | ||||
|---|---|---|---|---|---|---|
| Intervention N = 85 (%) |
Control N = 83 (%) |
p-value | Intervention N = 71 (%) |
Control N = 68 (%) |
p-value | |
| Primary outcomes | ||||||
| IV-to-PO conversion | 50 (58.8) | 35 (42.2) | 0.03 | 49 (69.0) | 33 (48.5) | 0.01 |
| Secondary outcomes | ||||||
| Clinical cure rate | 81 (95.3%) | 75 (90.4%) | 0.22 | 70 (98.6%) | 67 (98.5%) | 0.98 |
| Hospital mortality | 4 (4.7%) | 8 (9.6%) | 0.25 | 1 (1.4%) | 1 (1.5%) | 1.00 |
| Mean length of hospital stay (± SD, days) | 11.04 ± 8.30 | 13.99 ± 17.50 | 0.16 | 10.17 ± 8.21 | 14.37 ± 18.99 | 0.10 |
| Mean duration of intravenous FQs (± SD, days) | 6.02 ± 4.56 | 7.91 ± 10.78 | 0.14 | 6.01 ± 4.85 | 8.38 ± 11.68 | 0.12 |
| Mean duration of oral FQs (± SD, days) | 5.65 ± 6.78 | 5.48 ± 4.81 | 0.85 | 6.46 ± 6.52 | 6.21 ± 4.70 | 0.80 |
*All analyses were performed with clustering effect adjustment
In the modified intention to treat analysis, the intervention group demonstrated a significantly higher proportion of IV-to-PO conversion compared to the control group (69.0% vs. 48.5%; p-value = 0.01). Similar to the intention to treat analysis, there was no statistically significant differences between the intervention and control groups across any secondary outcomes, including the clinical cure rate (98.6% vs. 98.5%; p-value = 0.98), in-hospital mortality (1.4% vs. 1.5%; p-value = 1.00), mean length of hospital stay (10.17 ± 8.21 vs. 14.37 ± 18.99 days; p-value = 0.10), mean duration of intravenous FQ therapy (6.01 ± 4.85 vs. 8.38 ± 11.68 days; p-value = 0.12), and mean duration of oral FQ therapy (6.46 ± 6.52 vs. 6.21 ± 4.70 days; p-value = 0.80).
Discussion
Our findings suggest that a simple sticker reminder intervention is a useful tool for facilitating the transition from intravenous to oral FQ therapy. In this study, the proportion of IV-to-PO conversion increased from 42.2% in the control group to 58.8% in the intervention group. However, this success rate was lower than that reported in a similar study conducted in Malaysia, where the team pharmacists attached a printed checklist containing conversion criteria directly to the patient’s medical records once the criteria were met. In the Malaysian study, the proportion of IV-to-PO conversion reached 82.3% in the intervention group compared to 31.2% in the control group (p-value ≤ 0.001). The differences in efficacy and outcomes across these studies may be attributed to variations in the reminder mechanism, the level of pharmacist involvement, or differences in institutional protocols between settings [13].
Notably, approximately 40% of patients in the intervention group and 60% of those in the control group did not undergo IV-to-PO fluoroquinolone conversion despite meeting all established criteria. This observation indicates a substantial gap between patient eligibility and actual clinical practice and underscores the need for a deeper understanding of barriers to IV-to-PO conversion.
Furthermore, while we found no statistically significant differences in secondary outcomes such as LOS or duration of intravenous or oral FQ therapy, a study conducted in Ireland reported that a sticker reminder intervention significantly shortened the time to IV-to-PO conversion [14]. Conversely, a recent study suggested that successful IV-to-PO conversion might lead to a longer total duration of antimicrobial therapy, potentially due to less frequent re-evaluation of oral treatment compared to intravenous regimens or because physicians often prefer to prescribe longer duration of oral antibiotic regimen [7].
The study had several potential limitations. First, the study achieved only 75% of the target sample size. As a result, no statistically significant differences were observed in the secondary outcomes. These findings may indicate either a true lack of difference between groups or insufficient statistical power to detect such differences. Second, the study did not explore the reason of why a responsible physician did not perform IV-to-PO conversion among those who met all IV-to-PO conversion criteria. Third, the study was conducted during the COVID-19 pandemic, therefore this may somewhat affect or interact with the intervention effect. Given that the early discharge would reduce the risk for acquiring COVID-19 during hospitalization, the effect of sticker reminder may be overestimated. However, this effect was likely non-differential between the intervention and control groups.
The study had several strengths to be mentioned. The sticker reminder intervention is simple, cost-effective, and easy to implement in a busy clinical setting. Moreover, it could be incorporated into an automated alert system, reducing the implementation burden and facilitating wider adoption. Furthermore, the use of a cluster-randomized design reduced contamination by limiting interactions between study arms, as entire groups—rather than individuals—were assigned to the same condition, minimizing cross-exposure to the intervention. Finally, the study did not only focus on the proportion of IV-to-PO conversion, but also focused on clinical outcomes.
In conclusion, our findings indicate a positive association between the sticker reminder intervention and the proportion of IV-to-PO fluoroquinolone conversion. Future studies with larger sample sizes are warranted to further validate the benefits of this intervention across various clinical settings. Additionally, qualitative research is needed to explore the underlying factors contributing to physician hesitation in adopting IV-to-PO conversion protocols.
Electronic Supplementary Material
Below is the link to the electronic supplementary material.
Acknowledgements
The authors gratefully acknowledge the Siriraj antimicrobial stewardship (SiAMS) team and the SiData Plus team for their cooperation.
Author contributions
PR conceptualized the study design. JS, ST, and SS enrolled study subjects, implemented the intervention, and performed data collection. JS and ST cleaned and analyzed the data under PR’s supervision. All authors participated in drafting the manuscript. PR read and approved the final version of the manuscript.
Funding
This study was funded by the Health Systems Research Institute, Thailand (grant number: 67 − 012) and a Siriraj research grant (grant number: R016331061) from the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. The funding body was not involved in the design or execution of the study, the analysis of the study results or the preparation of the manuscript.
Data availability
The study dataset is available from the corresponding author upon reasonable request.
Declarations
Ethics approval and consent to participate
The study protocol was approved by the Institutional Review Board (IRB) of the Faculty of Medicine Siriraj Hospital, Mahidol University (COA #549/2020). A waiver of informed consent was granted for patients in the control group. For the intervention group, initial consent was obtained via telephone, followed by the completion of written informed consent prior to hospital discharge. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Jakaphan Sakchainan and Sumunthana Tunprayoon contributed equally to this work.
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Associated Data
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Supplementary Materials
Data Availability Statement
The study dataset is available from the corresponding author upon reasonable request.