article · BMJ Open

Clinical predictors of 3-month isoniazid rifapentine (3HP)-related adverse drug reactions (ADR) during tuberculosis preventive therapy (PAnDoRA-3HP study): an observational study protocol

Christine Sekaggya‐Wiltshire
Rogers Owori
Juliet Nampala
Florence Aber
Kelly E. Dooley
Eva Laker
Stavia Turyahabwe
Grace Banturaki
Josephine Bayigga
Barbara Castelnuovo
Jonathan Mayito
Brian Otaalo
Jotam G. Pasipanodya
Lucy Alinaitwe
Ruth Nabisere
Irene Mbabazi
Moorine Penninah Sekadde
Stella Zawedde‐Muyanja

2024Open accessMakerere University

Abstract

Ethical approval of this study inclusive of all the appropriate documents was obtained from the Infectious Diseases Institute Research and Ethics Committee and the Uganda National Council of Science and Technology. The study adheres to legal, ethical and Good Clinical Practice (GCP) guidelines. Deidentified genotype data from 300 patients will be shared after publication. The protocol and phenotype data will be publicly accessible. Abstracts will be submitted to conferences, and a manuscript will be published poststudy.

Research topics

Tuberculosis Research and Epidemiology
Infectious Diseases and Tuberculosis
Pharmacovigilance and Adverse Drug Reactions

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DOI: 10.1136/bmjopen-2024-088389

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