Methods | Randomized controlled trial Duration: 17 months, from January 1985 to June 1986 |
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Participants | Number: 120 infants enrolled (no age range specified) Inclusion criteria: post‐BCG vaccine lymphadenitis Exclusion criteria: patients with 'untoward' reactions (not adequately described) |
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Interventions | Group 1: isoniazid 10 mg/kg/day PO for two months Group 2: isoniazid plus rifampicin 10 mg/kg/day PO for two months Group 3: erythromycin 30 mg/kg/day PO for one month Group 4: no intervention |
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Outcomes | Clinical failure (abscess formation or lymph node size increased) | |
Notes | Location: Turkey Setting: not described Source of funding: not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described in the study |
Allocation concealment (selection bias) | Unclear risk | Not described in the study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Describe the evaluation of the outcome as 'blind' with no further explanations |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The authors describe that they were 'blind' to where participants were allocated, although they do not specify how |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | There was insufficient information to assess whether an important risk of bias exists |