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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2008060000861040 |
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Date of registration:
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08/02/2008 |
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Primary sponsor: |
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Public title:
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An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis
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Scientific title:
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An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2008060000861040 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a randomisation table created by a computer software program (i.e. computer sequence generation),
Sealed opaque envelopes and central allocation via telephone or internet,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Amina
Jindani |
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Address:
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Centre for Infection Department of Cellular and Molecular Medicine St. George?s, University of London Jenner Wing, Cranmer Terrace
SW17 0RE
London
United Kingdom |
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Telephone:
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+4420 8725 2801 |
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Email:
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ajindani@sgul.ac.uk |
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Affiliation:
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Chief Investigator |
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Name:
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Heather
Clouting |
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Address:
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MRC CTU, 222 Euston Rd
NW1 2DA
London
United Kingdom |
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Telephone:
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+44 207670 4749 |
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Email:
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hec@ctu.mrc.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Newly diagnosed pulmonary tuberculosis
2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy
3. Either no previous anti-tuberculosis chemotherapy, or less than two weeks of previous chemotherapy
4. Aged 18 years and over
5. A firm home address that is readily accessible for visiting and be intending to remain there during the entire treatment and follow up period
6. Willing to agree to participate in the study and to give a sample of blood for HIV testing
Exclusion criteria: 1. Has any condition (except HIV infection) that may prove fatal during the study period
2. Has Tuberculous (TB) meningitis
3. Has pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g., insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis
4. Is female and known to be pregnant, or breast feeding
5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or
Age minimum:
18 null
Age maximum:
100 null
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
null
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Primary Outcome(s)
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Combined rate of failure at the end of treatment and relapse,
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Occurrence of serious adverse events at any time during chemotherapy, recorded as they present themselves
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Presence of Rifamycin Monoresistance (RMR) in relapse cultures of HIV infected patients
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Secondary Outcome(s)
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Any adverse events
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Number of observed doses of chemotherapy ingested
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Rate of completion of chemotherapy according to the protocol
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Sputum culture results at two months after the initiation of chemotherapy,
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Source(s) of Monetary Support
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European and Developing Countries Clinical Trials Partnership
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