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Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial.

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Gonzalez, Carmen, Kranzer, Katharina, McHugh, Grace, Corbett, Elizabeth, Mujuru, Hilda, Nicol, Mark P, Rowland-Jones, Sarah, Rehman, Andrea M, Gutteberg, Tore J, Flaegstad, Trond, Odland, Jon O and Ferrand, Rashida A (2017) 'Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial.'. Trials, Vol 18, Issue 1, p. 622.

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Abstract

Human immunodeficiency virus (HIV)-related chronic lung disease (CLD) among children is associated with substantial morbidity, despite antiretroviral therapy. This may be a consequence of repeated respiratory tract infections and/or dysregulated immune activation that accompanies HIV infection. Macrolides have anti-inflammatory and antimicrobial properties, and we hypothesised that azithromycin would reduce decline in lung function and morbidity through preventing respiratory tract infections and controlling systemic inflammation. We are conducting a multicentre (Malawi and Zimbabwe), double-blind, randomised controlled trial of a 12-month course of weekly azithromycin versus placebo. The primary outcome is the mean change in forced expiratory volume in 1 second (FEV1) z-score at 12 months. Participants are followed up to 18 months to explore the durability of effect. Secondary outcomes are FEV1 z-score at 18 months, time to death, time to first acute respiratory exacerbation, number of exacerbations, number of hospitalisations, weight for age z-score at 12 and 18 months, number of adverse events, number of malaria episodes, number of bloodstream Salmonella typhi infections and number of gastroenteritis episodes. Participants will be followed up 3-monthly, and lung function will be assessed every 6 months. Laboratory substudies will be done to investigate the impact of azithromycin on systemic inflammation and on development of antimicrobial resistance as well as impact on the nasopharyngeal, lung and gut microbiome. The results of this trial will be of clinical relevance because there are no established guidelines on the treatment and management of HIV-associated CLD in children in sub-Saharan Africa, where 80% of the world's HIV-infected children live and where HIV-associated CLD is highly prevalent. ClinicalTrials.gov, NCT02426112 . Registered on 21 April 2015.

Item Type: Article
Subjects: QV Pharmacology > Anti-Bacterial Agents. Tissue Extracts > QV 350 Anti-bacterial agents (General or not elsewhere classified)
WA Public Health > WA 30 Socioeconomic factors in public health (General)
WA Public Health > Health Problems of Special Population Groups > WA 320 Child Welfare. Child Health Services.
WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections
WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.5 Complications
WF Respiratory System > WF 100 General works
WF Respiratory System > Lungs > WF 600 Lungs
WS Pediatrics > Diseases of Children and Adolescents > By System > WS 280 Respiratory system
WS Pediatrics > By Age Groups > WS 430 Infancy
WS Pediatrics > By Age Groups > WS 460 Adolescence (General)
Digital Object Identifer (DOI): https://doi.org/10.1186/s13063-017-2344-2
SWORD Depositor: JISC Pubrouter
Depositing User: JISC Pubrouter
Date Deposited: 08 Jan 2018 16:18
Last Modified: 09 Feb 2018 16:40
URI: http://archive.lstmed.ac.uk/id/eprint/8063

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