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-MuyanjaPublished 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
- end stage renal disease
- study protocol
- randomized controlled trial
- newly diagnosed
- clinical trial
- chronic kidney disease
- ejection fraction
- cross sectional
- stem cells
- emergency department
- electronic health record
- combination therapy
- hiv aids
- open label
- hepatitis c virus
- human immunodeficiency virus
- bone marrow
- double blind