Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201310000604277 Date of Registration: 29/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acetylation phenotype and clinical implications in tuberculosis patients
Official scientific title - Profile of Isoniazid Acetylation Phenotype and Clinical Implications in Rwandan Healthy Subjects and Tuberculosis Patients
Brief summary describing the background and objectives of the trial Numerous studies have been reported in literature demonstrating how an individual's genetic profile may be used for adjusting drug dosage. We designed this study to have indicative pictures on the normal profile of isoniazid acetylator phenotype, the effect of Tuberculosis (TB) on the profile, and the impact clinical responses.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2011
Actual trial start date 02/04/2011
Anticipated date of last follow up 03/04/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Healthy volunteers 10 mg/kg 12 hours Determination of Acetylation phenotype 20 Active-Treatment of Control Group
Experimental Group Clinical outcomes Daily dose of rifampin+isoniazid+pyrazinamide+ethambutol 2 months After phenotype determination, treat TB and monitor response and side effects 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy student volunteer Tuberculosis patient Consult the University hospital both sexes pregnancy under other treatment less than 15 years treated with ARVs 16 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/03/2011 CHUB ethics committee
Ethics Committee Address
Street address City Postal code Country
University street Huye 117 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Acetylator class: slow, intermediate, fast 8 hours after dosing
Secondary Outcome Impact of Phenotype on clinical outcomes monitor side effects weekly control sputum smear after 2 months control physical improvement weekly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medecine Universty street Huye 117 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
UE-ACP Edulink CHU - Avenue de l'Hôpital, 1 - Tour 4 - Bât. B36 Liege 4000 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NUR University street Huye 117 Rwanda University
COLLABORATORS
Name Street address City Postal code Country
Mukanyangezi M. Françoise University street Huye 117 Rwanda
Musemakweri André University street Huye 117 Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ntokamunda Justin Kadima kadima48@yahoo.com +250788422422 University street
City Postal code Country Position/Affiliation
Huye 117 Rwanda PG coordinator/National University of Rwanda
Role Name Email Phone Street address
Public Enquiries Andre Musemakweri amusemakweri@nur.ac.rw +250788592150 University street
City Postal code Country Position/Affiliation
Huye 117 Rwanda Physician/NUR CHUB
Role Name Email Phone Street address
Scientific Enquiries Marie Francoise Mukanyangezi mmukanyangezi@nur.ac.rw +250788672656 University street
City Postal code Country Position/Affiliation
Huye 117 Rwanda Assistant/NUR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information