| Study characteristics |
| Methods |
RCT, randomised 1:1
Double‐blinded
Double‐dummy |
| Participants |
Number of participants enrolled: 233 (19 negative culture)
Number of evaluated participants: 192
Number of dropouts: 31 (13%)
Setting: 11 paediatric offices in the USA
Age: 6 months to 12 years
Diagnosis: rapid antigen test, throat culture
Inclusion criteria: clinical diagnosis of acute streptococcal pharyngitis/tonsillitis, inflammation and swelling, with or without fever =/> 38 °C or exudate, rapid antigen test or throat culture positive for GABHS, history of compliance
Exclusion criteria: history of renal impairment (serum creatinine ≥ 177 µmol/L, 2.0 mg/dL), any condition that could preclude evaluation of response, requirement for systemic antibiotic, any antibiotic therapy within 3 days of start, hypersensitivity to penicillins and/or cephalosporins |
| Interventions |
Groups: loracarbef oral suspension, 15 mg/kg/day 2 divided doses, or 200 mg caps 2 per day (participant > 25 kg) (n = 120); penicillin VK oral suspension 20 mg/kg/day 4 doses, daily maximum 500 mg or 250 mg caps 4 per day (participant > 25 kg) (n = 113)
Duration of treatment: 10 days
Duration of follow‐up: 4 to 5 weeks |
| Outcomes |
Clinical outcomes at 3 to 5 days post‐treatment: cure (absence of presenting signs/symptoms); significant improvement (persistence of signs/symptoms); failure (insignificant change in signs/symptoms); relapse (recurrence of 1 or more signs/symptoms)
Relapse at 5 to 6 weeks post‐treatment
Adverse effects
Bacteriological outcomes |
| Notes |
Funding: Eli Lilly Company
Ethics approval: not mentioned
No ITT reported for efficacy, but ITT for adverse events |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Reported as "randomised (1:1)", but no reporting of randomisation sequence |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"Placebo was administered twice daily to the loracarbef group to maintain double blind conditions." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"unevaluable": 16 in loracarbef group and 25 in penicillin group (negative pre‐therapy culture, insufficient therapy, incomplete data, lost to follow‐up, late for visit, concomitant use of other antibiotic)
No ITT for clinical outcome |
| Selective reporting (reporting bias) |
Unclear risk |
ITT for adverse events |
| Other bias |
High risk |
Funding: Eli Lilly Company |
