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.: PACTR201406000609270 Date of Registration: 07/08/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Polymorphism of metabolisation and clinical implications
Official scientific title Profile of Isoniazid Acetylation Phenotype in Rwandan healthy subjects and Tuberculosis patients
Brief summary describing the background and objectives of the trial Numerous studies have demonstrated how an individual's genetic profile may be used for adjusting drug dosage and choosing a medication with minimal side effects. This study is to picture on the normal profile of acetylator phenotype, the effect of Tuberculosis (TB) on the profile, and the impact of the profile on the early clinical responses following treatment with the first line drugs.
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: Other
Anticipated trial start date 02/01/2012
Actual trial start date 01/03/2012
Anticipated date of last follow up 29/08/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
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 1 day Determination of Acetylation phenotype 40 Active-Treatment of Control Group
Experimental Group TB Patients RHZ (rifampicin 120mg/isoniazid 50 mg/pyrazinamide 300 mg); Ethambutol 400 mg. each day 2 months Effect of phenotype on treatment outcomes 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy individual Volunteer Tuberculosis patient Naive on TB and HIV drugs Inpatient No pregnancy No any medication 72 hours before 16 Year(s) 80 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
No National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University street Huye 117 Rwanda
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 01/11/2011 Butare Hospital Ethic 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 First week
Primary Outcome Impact of Phenotype on clinical outcomes End week 2 End week 4 End week 8
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butare University Teaching Hospital Universty street Huye 117 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
NUR research commission University street Huye 117 Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National University of Rwanda University street Huye 117 Rwanda University
COLLABORATORS
Name Street address City Postal code Country
Mukanyangezi M. Francoise University street Huye 117 Rwanda
Musemakweri Andre 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 Dr/Butare university teaching hospital
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/National University of Rwanda
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information