Methods | Randomized controlled trial Duration: dates not described |
|
Participants | Number: 18 enrolled infants Inclusion criteria: post‐BCG vaccine lymphadenitis Exclusion criteria: fluctuation of the adenitis |
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Interventions | Intervention group: isoniazid PO 10 mg/kg/day for a maximum of 9 months Control group: no intervention |
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Outcomes | Clinical failure (abscess formation/lymph node size increased) | |
Notes | Location: Dominica, West Indies 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 | High risk | Not performed, open study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
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 |