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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201209000394102 Date of Approval: 21/06/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment
Official scientific title Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment
Brief summary describing the background and objectives of the trial This research study will observe patients who are suffering from TB of their lungs, and receive standard TB treatment in Tanzania. The aim of this study is to establish the method of EBA in two research sites in Tanzania. This method will be used in the testing of new anti-TB medicines, should it be successfully established in the Tanzanian sites within this study. During this study, EBA will be compared with other methods of testing new anti-TB drugs, and some basic research on TB is done.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) OEBA TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2010
Actual trial start date 05/12/2011
Anticipated date of last follow up 02/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
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
Experimental Group Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment Standard dose 8 weeks Phase 2 efficacy study - time to stable culture conversion of patients on standard HRZE treatment following Tanzanian guidelines 140 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Provide informed consent (written or oral witnessed for illiterate patients) prior to all study-related procedures including HIV testing. Male and female patients of 18-65 years, weight range 31-90 kg Positive sputum smear for AFB bacilli (at least 1+ on the IUATLD/WHO scale). Ability to produce an adequate volume and quality of sputum as estimated from a spot assessment (estimated 10 mL or more overnight production). Karnofsky Score of at least 60 (requires occasional assistance but is able to care for most of his/her needs) Pre-menopausal women must have a negative pregnancy test and consent to an effective method of contraception, which includes at least one barrier method. If on Highly Active Antiretroviral Treatment (HAART), written confirmation of HAART compatibility with HRZE TB treatment from the treating physician is necessary. Poor general condition interfering with sputum production, warranting intensive care or with high likelihood of death before completion of study Patients for whom the study-inherent delay of at least two days for TB treatment initiation poses a significant risk Central nervous system TB or miliary TB. Drug resistance in the screening isolate (Rifampicin resistance) detected with a fast molecular assay on the screening sputum. Treatment received with drugs active against M. tuberculosis for more than 7 days within the last 2 months prior to Visit P3. This includes the standard TB drugs HRZE, second-line TB drugs like amikacin, cycloserine, rifabutin, rifapentine, gentamicin, streptomycin, kanamycin, para-aminosalicylic acid, thioacetazone, capreomycin, quinolones, thioamides. Contraindications to study drugs including standard TB treatment, such as a history of allergy, significant liver and/or kidney function abnormalities, e.g. AST or ALT elevated to >3x upper limit of normal, bilirubin of > 2x upper limit of normal, creatinine of >2x upper limit of normal on screening laboratory, which may be taken up to 7 days before visit P1 in the study site laboratory. Evidence of serious lung conditions other than TB. History and/or presence (or evidence) of optical neuritis. Diabetics using insulin. Evidence of clinically significant abnormalities which may interfere with TB and treatment according to the Investigator`s judgement, e.g. in metabolic, gastrointestinal, neurological, psychiatric or endocrine area as well as malignancy, Known or suspected alcohol or drug abuse which is judged to compromise the safety or cooperation of the patient. For recreational drug abuse, investigators may use some discretion in determining whether a patient should be excluded on this basis alone. Administration of an Investigational Medicinal Product within 1 month prior to Visit 1. Breast feeding or other circumstances with need for hospi 18 Year(s) 65 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 19/01/2011 NIMR - Mbeya Medical Research Program
Ethics Committee Address
Street address City Postal code Country
Referral Hospital Mbeya PO Box 419 Tanzania
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 20/06/2011 National Institute for Medical Reserch
Ethics Committee Address
Street address City Postal code Country
Dar es Salaam PO Box 9653 Tanzania
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 31/05/2011 Tumainii University, Kilimanjaro Christion Medical College
Ethics Committee Address
Street address City Postal code Country
Moschi PO Box 2240 Tanzania
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 27/04/2011 Ethikkommission der LMU München
Ethics Committee Address
Street address City Postal code Country
Pettenkoferstrasse 8 Munich 80336 Germany
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the decline in sputum bacillary counts in patients with newly diagnosed, sputum smear positive pulmonary TB during the first 14 days of standard HRZE treatment following Tanzanian guidelines, and to compare these values between patients and sites in order to demonstrate the feasibility of EBA studies in Tanzania in a two-site setting. 14 days
Secondary Outcome To train site staff in the methodology and conduct of EBA studies with the intention of establishing the capacity for this kind of studies with new anti-TB drug candidates in the trial sites. 14 Days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Clinical Research Institute Moshi, Kilimanjaro PO Box 2236 Tanzania
NIMR - Mbeya Medical Research Programme Mbeya PO box 2410 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP PO Box 93015 The Hague 2509AA Netherlands
BMBF Hannoversche Strasse 28 - 30 Berlin 10115 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Norbert Heinrich, Department fo Infectious Diseaes and Tropical Medicine, Klinium University of Munich (LMU) Georgenstrasse 5 Munich 80802 Germany University
COLLABORATORS
Name Street address City Postal code Country
Dr. Denis Ngetemelela Mbeya Tanzania
Prof. Gibson Kibiki Moschi, Kilimanjaro Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Norbert Heinrich heinrich@lrz.uni-muenchen.de +49 89 2180 17605 Leopoldstrasse 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Senior Scientist, Tuberculosis and Emerging Diseases
Role Name Email Phone Street address
Public Enquiries Norbert Heinrich heinrich@lrz.uni-muenchen.de +49 89 2180 17605 Leopoldstrasse 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Senior Scientist, Tuberculosis and Emerging Diseases
Role Name Email Phone Street address
Scientific Enquiries Norbert Heinrich heinrich@lrz.uni-muenchen.de +49 89 2180 17605 Leopoldstrasse 5
City Postal code Country Position/Affiliation
Munich 80799 Germany Senior Scientist, Tuberculosis and Emerging Diseases
REPORTING
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