PanACEA-MAMS-TB-01

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201205000383208
• Date of registration: 24/05/2012
• Primary sponsor: Prof. Burkhard G?ke, Medical Director, Klinikum of the Universtiy of Munich
• Public title: PanACEA-MAMS-TB-01
• Scientific title: A multiple arm, multiple stage (MAMS), phase 2, open label, randomized, controlled clinical trial to evaluate four treatment regimens including SQ109, two increased doses of rifampicin, and moxifloxacin in adult subjects with newly diagnosed, smear?positive pulmonary tuberculosis
• Date of first enrolment: 2013-01-11
• Target sample size: 372
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201205000383208
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Minimisation,; Open label,

Countries of recruitment

South Africa

Contacts

• Name: Anna-Maria Mekota
• Affiliation: Project manager

• Name: Norbert Heinrich
• Affiliation: Seniro Scientist

Key inclusion & exclusion criteria

Inclusion criteria: 1. The patient has given free, signed written or witnessed oral informed consent for study participation prior to all trial-related procedures, including HIV testing. ago.
2. The patient has a diagnosis of pulmonary TB.
3. An adequate sputum bacterial load is confirmed by a Ziehl-Neelsen stained smear in the study laboratory.
4. The patient has a valid rapid test result (GeneXpert MTB/RIF?) from the sputum positive for MTB complex, and indicating susceptibility to Rifampicin.
5. The patient is aged at least 18 years at the day of informed consent.
6. The patient has a body weight of at least 35 kg, but not more than 90 kg.
7. Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practise an effective method of birth control until week 26.
8. Male patients must consent to use an effective contraceptive method, if their sexual partner(s) is/are of childbearing potential, and if they are not surgically sterile.
9. The patient has a firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period, or will be compliant to study schedule and follow-up in the discretion of the investigator.

Exclusion criteria: 1. Circumstances that raise doubt about free, uncoerced consent to study participation.
2. Poor General Condition.
3. The patient is pregnant or breast-feeding.
4. The patient has an HIV infection.
5. The patient has a known intolerance to any of the study drugs, or concomitant disorders or conditions for which SQ109, rifampicin, moxifloxacin, or standard TB treatment are contraindicated.
6. The patient has an history or evidence of clinically relevant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator.
7. History of previous TB within the last five years.
8. Laboratory: at screening one or more of the following abnormalities were observed for the patient in screening laboratory: AST and/or ALT activity b3x the upper limit of normal, serum total bilirubin level b2.5 times the upper limit of normal, Creatinine clearance (CrCl) level greater than 30 mls/min, Complete blood count with hemoglobin level `7.0 g/dL, Platelet count `50,000/mm3, Serum potassium below the lower level of normal
9. ECG findings in the screening ECG: QTcB and/or QTcF of b0.450 s, AV block with PR interval b 0.20 s, prolongation of the QRS complex over 120 milliseconds, other changes in the ECG that are clinically relevant as per discretion of the investigator.
10. The patient has had treatment with any other investigational drug within 1 month prior to enrolment.
11. Previous anti-TB treatment.
12. QT prolonging medications.
13. CYP 450 inducers/inhibitors: administration within 30 days prior to dosing.

Age minimum: 18 Year
Age maximum: 150 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
null

Primary Outcome(s)

Time to stable culture conversion to negative in liquid media defined as the time from enrolment to the first of two negative weekly sputum cultures without an intervening positive culture in liquid media.

Source(s) of Monetary Support

EDCTC

Sequella, Inc.

BMBF