Somekh 2000.

Study characteristics
Methods	2‐arm, non‐blinded, parallel‐group RCT, with 10 to 14 days duration of treatment and 90 days of follow‐up post‐hospital discharge
Participants	Location: Israel, single site Setting of recruitment and treatment: inpatient, at the Pediatric Infectious Diseases Unit, E. Wolfson Medical Center (affiliated to Tel Aviv University) Sample size: Number randomised: 15 in intervention, 15 in comparison Number completed: 15 in intervention, 15 in comparison Participant (baseline) characteristics: Age: 1 to 12 years, mean 4.2 years Gender (F/M): not reported Main diagnosis: pseudomonal CSOM High‐risk population: no Cleft palate (or other craniofacial malformation): not reported Down syndrome: not reported Indigenous groups (Australian Aboriginals/Greenland natives): not reported Immunocompromised: not reported Diagnosis method: Confirmation of perforated tympanic membrane: yes, method not specified Presence of mucopurulent discharge: yes Duration of symptoms (discharge): mean 8 weeks (range 8 to 12 weeks) Other important effect modifiers: Alternative diagnosis of ear discharge: none Number who have previously had grommets inserted: not reported Number who have had previous ear surgery: not reported Number who had previous antibiotic treatment for CSOM: 30/30 (100%). All had failed at least one antibiotic treatment. Inclusion criteria: Documented otorrhoea through a perforation or a patent tympanostomy for more than 6 weeks Pure culture of Pseudomonas aeruginosa growing from middle ear aspiration Age 6 months to 15 years Failure of at least 1 complete conventional oral antibiotic course No topical or systemic antibiotics during the week before enrolment Exclusion criteria: Evidence of cholesteatoma Known or suspected hypersensitivity to ceftazidime or aztreonam Presence of an underlying serious condition Abnormality of hepatic or renal function tests
Interventions	Intervention (n = 15): intravenous aztreonam 100 mg/kg/day in 3 divided doses Comparator(n = 15): intravenous ceftazidime 100 mg/kg/day in 3 divided doses Concurrent treatment: all patients had daily suction and debridement until complete cessation of discharge. Treatment was continued until 3 days after complete cessation of discharge and for at least 10 days. Treatment was discontinued if there was no sign of remission after 14 days of treatment; development of resistance of the bacteria to the antibiotic used; or appearance of a serious complication related to the drug.
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge or "dry ear" (whether otoscopically confirmed or not) measured at 2 to 4 weeks and after 4 weeks. Unclear if otoscopically confirmed. Secondary outcomes: Not reported
Funding sources	No information provided
Declarations of interest	No information provided
Notes	Unit of randomisation: person Methods for reporting outcomes of patients with bilateral disease: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were initially randomly assigned..." Comment: no details provided.
Allocation concealment (selection bias)	Unclear risk	Comment: no details provided about allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "this prospective, open, randomized study." Comment: no blinding. Unclear how this could have affected treatment.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: open‐label study. There is subjectivity in the assessment of outcome.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: no dropout was reported.
Selective reporting (reporting bias)	Unclear risk	Comment: study protocol not found. Insufficient information to judge.