Methods | Randomized controlled trial Duration: 13 months, from November 1987 to December 1988 |
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Participants | Number: 96 infants enrolled: 69 with lymphadenitis; 27 with abscess formation Inclusion criteria: infants with lymphadenitis or abscess with a diameter of at least 2 cm within 6 months of BCG vaccination Exclusion criteria: not stated |
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Interventions | Group A (lymphadenitis group): received either 1) erythromycin PO (50 mg/kg/day for one month) or 2) oral placebo. Group B (abscessed group): all had their abscess aspirated, then randomized to 1) erythromycin PO (50 mg/kg/day for one month) plus a single local instillation of saline (placebo), or 2) oral placebo plus locally instilled isoniazid (50 mg single dose) |
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Outcomes | Clinical failure (abscess formation/lymph node size increased) | |
Notes | Location: Jamaica Setting: emergency department community based‐trial 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 | Low risk | Use of placebo (coloured sugar water). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Although subjective, the authors clearly define 'clinical resolution' |
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 |