Survival of Patients with Tuberculosis in Retreatment Programme with Guardian Administered Streptomycin in Malawi
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Date
2021-07
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Addis Abeba University
Abstract
Background: Current ambulatory approaches for delivering treatment to patients with
tuberculosis in Malawi have significant operational delivery challenges. This led to a clinical
trial aimed at establishing if guardian administered streptomycin is non-inferior to hospital
administered streptomycin. In order to establish effectiveness of guardian administered
streptomycin, all integral outcomes including survival need to be assessed.
Objectives: Based on secondary analysis of existing trial dataset, this study aimed to compare
survival of patients with tuberculosis who received streptomycin administered at hospital or at
home by a guardian controlling for potential factors that may confound or mediate effect of
the treatments.
Methods: In the original study - a non-inferiority, parallel, randomised, open label, phase III
trial –204 patients were randomized to receive streptomycin at the hospital or in their homes
where it was administered by a patient nominated guardian. One hundred and one patients were
randomized into hospital arm while 103 into home-based group. Patients were followed up for
ten months. In this study, comparison of survival between the treatment delivery options
employed Logrank test. Cox proportional hazard model was used to identify factors that
confound or mediate survival of patients. Potential factors included age, sex, TB class, TB
category, HIV status, smoking status, drinking status and employment status of participants and
education level of household head.
Results: No significant difference was observed in survival of patients between the two groups
(p-value = 0.726, HR 1.15 (0.52 to 2.55). All covariates except unemployment had no effect on
survival of patients (CI for HR had 1).
Conclusion: Use of patient nominated trained lay carers to administer streptomycin provides a
potential convenient and cost-effective approach for treating patients with recurrent and drug
resistant TB. However, decision for its adoption should be cautious due to small sample size used, switching of critically ill patients from home-based group to hospital arm, inadequate
information on how patients selected guardians and lack of details on how TB resistance was
assessed. A follow up study on assessment of acceptability of the proposed model of care would
help understand if it could be successfully adopted and used to deliver long term TB injectable
agents to patients.
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Keywords
Tuberculosis,Patients