Nemeth 1999.

Study characteristics
Methods	RCT, randomised 1:1:1 Double‐blinded Double‐dummy
Participants	Number of participants enrolled: 919 Number of positive throat cultures susceptible to study drugs: 725 Number of participants evaluated: 644 Number of dropouts: 275 (30%) Setting: 25 study centres in the USA and Canada Age: =/> 13 years Diagnosis: rapid antigen test, throat culture Inclusion criteria: throat culture positive for GABHS, at least 1 clinical sign or symptom of pharyngitis Exclusion criteria: pregnancy, history of rheumatic fever or rheumatic heart disease, peritonsillar abscess or invasive disease, hypersensitivity to beta‐lactam drugs, hepatic disease, hepatic enzyme levels or serum creatinine > 2 times upper limit of normal, another systemic antibiotic within 3 days before first dose of study medication or for which < 5 half‐lives had elapsed, enrolled in this study previously, received another investigational drug within 4 weeks before study admission
Interventions	Groups: cefdinir 600 mg 4 times a day (n = 305); cefdinir 300 mg twice a day (n = 304); penicillin V 250 mg 4 times a day (n = 310) Duration of treatment: 10 days Duration of follow‐up: 17 to 24 days post‐therapy
Outcomes	Clinical outcomes at day 4 to 9 after treatment: cure (all signs and symptoms absent or in satisfactory remission and no further antibiotic therapy required); failure (absence of significant remission of signs and symptoms or need for further antibiotic therapy); relapse (worsening of, or absence of significant remission of, signs and symptoms 17 to 24 days post‐therapy or need for further antibiotic therapy) Relapse at day 17 to 24 after treatment Adverse effects Bacteriological outcomes
Notes	Funding: Parke‐Davis Pharmaceutical Research, Ann Arbor, MI, USA (first author is employee) Informed consent obtained. Ethics approval: institutional review board approval obtained at each site No ITT for efficacy reported, but ITT for adverse events.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Reported as "randomised", but no description of the randomisation sequence
Allocation concealment (selection bias)	Unclear risk	"Patients were randomly assigned in a 1:1:1 ratio."
Blinding (performance bias and detection bias) All outcomes	Unclear risk	"All participants took the same number of capsules daily. All regimens were administered for 10 days." No description of the appearance of the capsules
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropouts 275: no GABHS at admission culture (194); failure to return or non‐compliance (not specified in which group) 30% dropout No ITT analysis for clinical outcomes
Selective reporting (reporting bias)	Unclear risk	Only clinical cure reported, no symptoms specified. Adverse events analysed by ITT: 21 participants discontinued due to adverse events (cefdinir = 17, penicillin V = 4); difference between groups is not significant.
Other bias	High risk	Funding: Parke‐Davis Pharmaceutical Research, Ann Arbor, MI, USA (first author is employee)