Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP) - Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy. (PAnDoRA-3HP study): An Observational Study Protocol.

Christine Wiltshire SekaggyaIrene MbabaziRuth Nabisere-ArinaitweGrace BanturakiLucy AlinaitweBrian OtaloFlorence AberJuliet NampalaRogers OworJosephine BayigaEva Laker Agnes OdongpinyBarbara CastelnuovoJonathan MayitoMoorine SekaddeJotam G PasipanodyaStavia TuryahabweStella Zawedde-Muyanja

Published in: medRxiv : the preprint server for health sciences (2024)

The safety profile of 3HP will be assessed using descriptive statistics, including proportions of patients experiencing ADRs and grade 3 or above events related to treatment. Chi-square tests and regression models will determine predictors of ADRs and their impact on treatment completion. Pharmacokinetic-pharmacodynamic modeling will establish population parameters and factors influencing rifapentine and isoniazid concentrations.

Keyphrases

adverse drug
mycobacterium tuberculosis
study protocol
randomized controlled trial
end stage renal disease
newly diagnosed
ejection fraction
clinical trial
chronic kidney disease
cross sectional
stem cells
hiv infected