BACKGROUND: Response to treatment may be useful for diagnostic confirmation of childhood tuberculosis (TB). We aimed to evaluate time to symptom resolution in children treated for pulmonary TB. METHODS: We compared pulmonary TB cases and noncases, classified by a published diagnostic algorithm, in South African children younger than 2. TB treatment was prescribed independently on clinical grounds. We analyzed independent determinants of baseline symptom resolution by Cox regression. RESULTS:One hundred and ninety-one symptomatic children, median age 12 months, were prescribed for TB treatment. Chest radiograph features of TB were associated with longer time to resolution of cough (adjusted hazard ratio, AHR 0.31), wheeze (AHR 0.26) and failure to thrive (AHR 0.41), (all P < 0.05). However, median duration of baseline cough (63 vs. 70 days, P = 0.98), wheeze (62 vs. 68 days, P = 0.87) and failure to thrive (76 vs. 66 days, P = 0.59) did not differ in TB cases (n = 48) versus noncases (n = 46). CONCLUSIONS: Baseline symptoms take more than 60 days to resolve in the majority of young children after starting TB treatment. Furthermore, since time to resolution does not differentiate TB cases from noncases; clinical response to treatment is not an appropriate diagnostic criterion for pediatric trials of TB diagnostics, drugs and vaccines.
RCT Entities:
BACKGROUND: Response to treatment may be useful for diagnostic confirmation of childhood tuberculosis (TB). We aimed to evaluate time to symptom resolution in children treated for pulmonary TB. METHODS: We compared pulmonary TB cases and noncases, classified by a published diagnostic algorithm, in South African children younger than 2. TB treatment was prescribed independently on clinical grounds. We analyzed independent determinants of baseline symptom resolution by Cox regression. RESULTS: One hundred and ninety-one symptomatic children, median age 12 months, were prescribed for TB treatment. Chest radiograph features of TB were associated with longer time to resolution of cough (adjusted hazard ratio, AHR 0.31), wheeze (AHR 0.26) and failure to thrive (AHR 0.41), (all P < 0.05). However, median duration of baseline cough (63 vs. 70 days, P = 0.98), wheeze (62 vs. 68 days, P = 0.87) and failure to thrive (76 vs. 66 days, P = 0.59) did not differ in TB cases (n = 48) versus noncases (n = 46). CONCLUSIONS: Baseline symptoms take more than 60 days to resolve in the majority of young children after starting TB treatment. Furthermore, since time to resolution does not differentiate TB cases from noncases; clinical response to treatment is not an appropriate diagnostic criterion for pediatric trials of TB diagnostics, drugs and vaccines.
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