Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment

• Register: PACTR
• Last refreshed on: 27 May 2013
• Main ID: PACTR201209000394102
• Date of registration: 21/06/2012
• Primary sponsor: Dr. Norbert Heinrich, Department fo Infectious Diseaes and Tropical Medicine, Klinium University of Munich (LMU)
• Public title: Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment
• Scientific title: Observation of Early Bactericidal Activity of Standard Tuberculosis Treatment
• Date of first enrolment: 2011-12-05
• Target sample size: 140
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201209000394102
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Norbert Heinrich
• Affiliation: Senior Scientist, Tuberculosis and Emerging Diseases

• Name: Norbert Heinrich
• Affiliation: Senior Scientist, Tuberculosis and Emerging Diseases

Key inclusion & exclusion criteria

Inclusion criteria: 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.

Exclusion criteria: 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 b3x upper limit of normal, bilirubin of b 2x upper limit of normal, creatinine of b2x 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

Age minimum: 18 Year
Age maximum: 65 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
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Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

EDCTP

BMBF