TuberculosisPhase 4NCT00216333
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
A Phase 4 study testing combined fixed dose combination in people with Tuberculosis, run by International Union Against Tuberculosis and Lung Diseases at 9 sites in 9 countries.
Trial summary
The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- combined fixed dose combination
- How many people
- 1,500 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Dec 2003to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed pulmonary tuberculosis
- two sputum specimens positive for acid-fast bacilli on direct smear microscopy
- no previous anti-tuberculosis chemotherapy
- aged 18 years and over
- firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
- agree to participate in the study and to give a sample of blood for HIV test
Who cannot join
- patients in a moribund state,
- TB meningitis,
- pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
- pregnancy or breast feeding,
- psychiatric illness
- alcoholism
- contraindication to any medications in the study regimens
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Algeria1 site, 1 recruiting
- Not yet recruiting
Service de Pneumo-phtisiologie de Matiben
Algiers
Noureddine Zidouni, MD, 213-21 93 13 86, nzidouni@sante.dz
Noureddine Zidouni, MD
Bolivia1 site, 1 recruiting
- Recruiting
Program Nal. de Control de la Tuberculosis
Santa Cruz
Mirtha Camacho, MD, 59122211275, tbcos@hotmail.com
Segondo Guzman, MD
Colombia1 site, 1 recruiting
- Recruiting
Centro Internacional de Entrenamiento
Cali
Dr Juan Francisco Miranda, MD, 57 2 668 2164, mirandaf@cideim.org.co
Gustavo Montero, MD
Guinea1 site, 1 recruiting
- Recruiting
CHU Ignace Deen
Conakry
Mamadou D BARRY, MD, 224 29 86 40, mdtelibarry@yahoo.fr
Boubacar BAH, MD
Mozambique1 site, 1 recruiting
- Recruiting
Health Resesarch Center of Manhica
Manhiça
Mateu Dr Mateu Espasa, MD, + 258 1 81 01 81, mateu.espasa@manhica.net
Mateu Espasa, MD
Peru1 site, 1 recruiting
- Recruiting
Grupo Levir S.A.
Lima
Víctor Manuel Chávez Pérez, MD, +51-1-328-2451, chzpz@viabcp.com
Eduardo Ticona, MD
Tanzania1 site
- Active, not recruiting
National Institute for Medical Research
Mwanza
Vietnam1 site, 1 recruiting
- Recruiting
National Hospital of TB and Respiratory Diseases
Hanoi
Sy Dinh Ngoc, MD, PhD, 0913284158, vnntp463@hn.vnn.vn
Thuy Ha, MD
About this study
Official title: International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis
The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.
Read the detailed description
This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs.
Patients will be allocated at random either :
- an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose COMBINED tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2COMB/4(RH)3) or
- the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2SEPA/4(RH)3)
- Conditions
- Tuberculosis
- Being tested
- combined fixed dose combination
- Keywords
- tuberculosis, fixed dose combination, DOT, shot-course chemotherapy
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined fixed dose combinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.
Safety : occurrence of serious adverse events at any time during chemotherapy
Secondary outcomes (2)
Sputum culture results at two months of chemotherapy
Rate of completion of chemotherapy according to the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- International Union Against Tuberculosis and Lung Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Investigators
- Christian Lienhardt, MD, Study director, International Union Against Tuberculosis and Lung Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216333
- Sponsor's protocol ID
- IUATLD CT Study C
- Status last verified
- Sep 2006
- First submitted
- 20 Sep 2005
- Last updated
- 13 Sep 2006
- Results posted
- No
Publications
Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23. doi: 10.1001/jama.2011.436.
PubMed 21486974
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00216333
- Acronym / sponsor ID
- IUATLD CT Study C
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, fixed dose combination, DOT, shot-course chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants
- Lead sponsor
- International Union Against Tuberculosis and Lung DiseasesUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Dec 2003
- Study completion
- Jun 2007
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.
Detailed description
This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs.
Patients will be allocated at random either :
- an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose COMBINED tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2COMB/4(RH)3) or
- the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2SEPA/4(RH)3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with newly diagnosed pulmonary tuberculosis
- two sputum specimens positive for acid-fast bacilli on direct smear microscopy
- no previous anti-tuberculosis chemotherapy
- aged 18 years and over
- firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
Key exclusion criteria (7 listed)
- patients in a moribund state,
- TB meningitis,
- pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
- pregnancy or breast feeding,
- psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined fixed dose combination | Drug | – |
Primary outcome
Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.
Safety : occurrence of serious adverse events at any time during chemotherapy
2 secondary outcomes
Sputum culture results at two months of chemotherapy
Rate of completion of chemotherapy according to the protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
- Derived from this study: PubMed 21486974Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23. doi: 10.1001/jama.2011.436.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Lienhardt, MD study director
International Union Against Tuberculosis and Lung Diseases
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing combined fixed dose combination in people with Tuberculosis, run by International Union Against Tuberculosis and Lung Diseases at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Algeria, Bolivia, Colombia, Guinea, Mozambique and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharlette Cook, MPH (+33 1 44 32 06 47, scook@iuatld.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00216333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2006.