The main objective of the study is to investigate whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-infected children with chronic lung disease, who are stable on antiretroviral therapy. Lung function will be assessed using spirometry, Forced Expiratory Volume in the first second being the primary outcome. We will also evaluate acute exacerbations, number of hospitalizations and adverse events related to azithromycin treatment.
Study design and participants
BREATHE is a multi-site, individually randomised, double-blinded, placebo-controlled trial. We will recruit 400 HIV infected children with CLD aged 6-16 years in two hospitals in Harare, Zimbabwe and Blantyre, Malawi. Children will be randomised to either the control group or to a weekly weight-based dose of azithromycin for 12 months. Follow up duration will be 18 months. The study will be conducted between March 2016 and December 2019.
|BREATHE is a joint project between Norway, United Kingdom, South African Republic, Zimbabwe and Malawi.|
Trial incorporates several sub-studies. Cardiac symptoms, echocardiographic findings and the effects of azithromycin treatment on right-sided cardiac function and/or pulmonary hypertension will be evaluated during cardiac sub-study.
In the immunological sub-study plasma levels of biomarkers of systemic and pulmonary inflammation, microbial translocation and immune activation will be evaluated before and after azithromycin treatment.
Laboratory sub-study will investigate the diversity and composition of the respiratory and gut microbiome, determine the effect of azithromycin therapy on antimicrobial resistance in bacteria colonizing the respiratory tract.
BREATHE- Bronchopulmonary function in response to azithromycin treatment for chronic lung disease in HIV - infected children