TuberculosisPhase 2NCT00144417
TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment
A Phase 2 study testing Moxifloxacin (with rifampin, pyrazinamide, and ethambutol) and isoniazid in people with Tuberculosis, run by Centers for Disease Control and Prevention at 26 sites in 6 countries.
Trial summary
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Moxifloxacin (with rifampin, pyrazinamide, and ethambutol) and isoniazid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Feb 2006to Dec 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. Patients whose sputum cultures do not grow M. tuberculosis and those having an M. tuberculosis isolate resistant to (one or more) isoniazid, rifampin, fluoroquinolones, will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment. Sputum must be expectorated or induced; smear results from respiratory secretions obtained by bronchoalveolar lavage or bronchial wash may not be used for assessment of study eligibility.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment. HIV testing does not need to be repeated if there is written documentation of a positive test (positive ELISA and Western Blot or a plasma HIV-RNA level greater than 5000 copies/ml) at any time in the past.
- 7 (seven) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment.
- 7 (seven) or fewer days of fluoroquinolone therapy in the 3 months preceding enrollment.
- Age > 18 years
- Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix B).
Show all 16Show fewer
- Signed informed consent
- Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
- Laboratory parameters done at, or <14 days prior to, screening:
- Serum amino aspartate transferase (AST) activity ≤ 3 times the upper limit of normal
- Serum total bilirubin level ≤ 2.5 times the upper limit of normal
- Serum creatinine level ≤ 2 times the upper limit of normal
- Complete blood count with hemoglobin level of at least 7.0 g/dL
- Complete blood count with platelet count of at least 50,000/mm3
- Serum potassium > 3.5 meq/L
- Negative pregnancy test (women of childbearing potential)
Who cannot join
- Breast-feeding
- Known intolerance to any of the study drugs
- Known allergy to any fluoroquinolone antibiotic
- Concomitant disorders or conditions for which moxifloxacin (MXF), isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
- Current or planned therapy during the intensive phase of therapy using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy).
- Current or planned antiretroviral therapy during the intensive phase of therapy.
Show all 9Show fewer
- History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine during the intensive phase of therapy.
- Pulmonary silicosis
- Central nervous system TB
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States20 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
Boston University Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
Denver Public Health Department
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
University of North Texas Health Science Center
Fort Worth, Texas, 76104
Hines Veterans Administration Medical Center
Hines, Illinois, 60141
Houston Veterans Administration Medical Center
Houston, Texas, 77030
Veterans Administration Medical Center of Arkansas
Little Rock, Arkansas, 72205
University of Southern California Medical Center
Los Angeles, California, 90033
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
Harlem Hospital, Columbia University
New York, New York, 10037
New Jersey School of Medicine
Newark, New Jersey, 07103
Audie L Murphy Memorial Veterans Administration Medical Center
San Antonio, Texas, 78284
University of California at San Diego
San Diego, California, 92103
University of California, San Francincisco
San Francisco, California, 94110
Seattle-King County Health Department
Seattle, Washington, 98104
Washington DC Veterans Administration Medical Center
Washington D.C., District of Columbia, 20422
Canada2 sites
Montreal Chest Institute
Montreal, Quebec, H2X 2P4
University of Manitoba
Winnepeg, Manitoba, R3A 1R8
Brazil1 site
Hopital Universitario Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 2194.590
South Africa1 site
Nelson R. Mandela School of Medicine
Durban, KwaZulu-Natal
About this study
Official title: TBTC Study 28: Evaluation of a Moxifloxacin-based, Isoniazid-sparing Regimen for Tuberculosis Treatment
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.
Read the detailed description
The primary objective of this Phase 2 clinical trial is to compare the safety and antimicrobial activity of a moxifloxacin-containing regimen (moxifloxacin, rifampin, pyrazinamide, ethambutol [MRZE]) in which moxifloxacin has been substituted for isoniazid, to the standard control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis. The assessment of antimicrobial activity will be sputum culture-conversion. Higher rates of sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen would support Phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens.
Rationale - Current treatment of smear positive pulmonary tuberculosis requires a minimum of 6 months, a treatment duration that is challenging for patients and tuberculosis control programs. Therefore, a high priority in tuberculosis research is the identification of agents that can shorten treatment. Several fluoroquinolone antibiotics have potent activity against Mycobacterium tuberculosis (M. tuberculosis) in preclinical testing. Of the currently available fluoroquinolones, moxifloxacin has excellent activity in vitro and in animal models of tuberculosis, a favorable pharmacokinetic profile (serum half-life of 10-12 hours), lack of problematic drug-drug interactions, no need for dosage adjustment for renal and hepatic insufficiency, and an excellent safety profile. In addition, in the murine model of tuberculosis, the substitution of moxifloxacin for isoniazid resulted in significant reductions in the time to culture conversion and the time to sterilization when compared to the standard combination rifampin, isoniazid and pyrazinamide. However, moxifloxacin has not been fully evaluated in humans for tuberculosis treatment. There is a need to assess not only the anti-tuberculosis activity of moxifloxacin-containing regimens, but also the safety of more prolonged therapy with moxifloxacin.
Two-month culture conversion rates are a well-accepted surrogate marker for the sterilizing activity of anti-tuberculosis drugs. Rifampin and pyrazinamide, the key drugs in current 6-month regimens, markedly increase 2-month culture-conversion rates. Therefore, this study will use 2-month culture conversion rate as the measure of antimicrobial activity of moxifloxacin.
- Conditions
- Tuberculosis
- Being tested
- Moxifloxacin (with rifampin, pyrazinamide, and ethambutol), isoniazid
- Keywords
- tuberculosis, TB, treatment, efficacy, safety
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (with rifampin, pyrazinamide, and ethambutol)Drug
Moxifloxacin 400mg daily, 8 weeks
isoniazidDrug
isoniazid, oral, 300 mg, daily, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| HRZE | Active comparator | isoniazid, rifampin, pyrazinamide, ethambutol, moxifloxacin-placebo Receives: Drug: isoniazid |
| MRZE | Experimental | moxifloxacin, rifampin, pyrazinamide, ethambutol, isoniazid-placebo Receives: Drug: Moxifloxacin (with rifampin, pyrazinamide, and ethambutol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen
Measured: 8 weeks
Secondary outcomes (6)
To compare the safety and tolerability of the moxifloxacin regimen to that of the isoniazid regimen
Measured: 8 weeks
To determine the time to culture-conversion of the moxifloxacin regimen and the isoniazid regimen using data from 2-, 4-, 6-, and 8-week cultures
Measured: 8 weeks
To compare the proportion of patients with any Grade 3 or 4 adverse reactions
Measured: 8 weeks
To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients
Measured: 8 weeks
To compare the rates of treatment failure of the moxifloxacin regimen and the isoniazid regimen
Measured: 6 months
To determine whether there is delayed toxicity attributable to moxifloxacin (toxicity that becomes evident after the 8 weeks of moxifloxacin therapy)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2006
- Primary completionJun 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Global Alliance for TB Drug Development, Bayer
- Investigators
- Richard E Chaisson, MD, Study chair, Johns Hopkins UniversitySusan E Dorman, MD, Principal investigator, Johns Hopkins UniversityJohn L Johnson, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144417
- Sponsor's protocol ID
- CDC-NCHSTP-4448
- Status last verified
- Jun 2011
- First submitted
- 1 Sep 2005
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dorman SE, Johnson JL, Goldberg S, Muzanye G, Padayatchi N, Bozeman L, Heilig CM, Bernardo J, Choudhri S, Grosset JH, Guy E, Guyadeen P, Leus MC, Maltas G, Menzies D, Nuermberger EL, Villarino M, Vernon A, Chaisson RE; Tuberculosis Trials Consortium. Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis. Am J Respir Crit Care Med. 2009 Aug 1;180(3):273-80. doi: 10.1164/rccm.200901-0078OC. Epub 2009 Apr 30.
PubMed 19406981Zhang N, Savic RM, Boeree MJ, Peloquin CA, Weiner M, Heinrich N, Bliven-Sizemore E, Phillips PPJ, Hoelscher M, Whitworth W, Morlock G, Posey J, Stout JE, Mac Kenzie W, Aarnoutse R, Dooley KE; Tuberculosis Trials Consortium (TBTC) and Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) Networks. Optimising pyrazinamide for the treatment of tuberculosis. Eur Respir J. 2021 Jul 20;58(1):2002013. doi: 10.1183/13993003.02013-2020. Print 2021 Jul.
PubMed 33542052Mac Kenzie WR, Heilig CM, Bozeman L, Johnson JL, Muzanye G, Dunbar D, Jost KC Jr, Diem L, Metchock B, Eisenach K, Dorman S, Goldberg S. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa. PLoS One. 2011 Apr 11;6(4):e18358. doi: 10.1371/journal.pone.0018358.
PubMed 21494548
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBTC Study 28: Evaluation of a Moxifloxacin-based, Isoniazid-sparing Regimen for Tuberculosis Treatment
- ClinicalTrials.gov ID
- NCT00144417
- Acronym / sponsor ID
- CDC-NCHSTP-4448
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, TB, treatment, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Global Alliance for TB Drug Development, Bayer
- Study start
- Feb 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 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.
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.
Detailed description
The primary objective of this Phase 2 clinical trial is to compare the safety and antimicrobial activity of a moxifloxacin-containing regimen (moxifloxacin, rifampin, pyrazinamide, ethambutol [MRZE]) in which moxifloxacin has been substituted for isoniazid, to the standard control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis. The assessment of antimicrobial activity will be sputum culture-conversion. Higher rates of sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen would support Phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens.
Rationale - Current treatment of smear positive pulmonary tuberculosis requires a minimum of 6 months, a treatment duration that is challenging for patients and tuberculosis control programs. Therefore, a high priority in tuberculosis research is the identification of agents that can shorten treatment. Several fluoroquinolone antibiotics have potent activity against Mycobacterium tuberculosis (M. tuberculosis) in preclinical testing. Of the currently available fluoroquinolones, moxifloxacin has excellent activity in vitro and in animal models of tuberculosis, a favorable pharmacokinetic profile (serum half-life of 10-12 hours), lack of problematic drug-drug interactions, no need for dosage adjustment for renal and hepatic insufficiency, and an excellent safety profile. In addition, in the murine model of tuberculosis, the substitution of moxifloxacin for isoniazid resulted in significant reductions in the time to culture conversion and the time to sterilization when compared to the standard combination rifampin, isoniazid and pyrazinamide. However, moxifloxacin has not been fully evaluated in humans for tuberculosis treatment. There is a need to assess not only the anti-tuberculosis activity of moxifloxacin-containing regimens, but also the safety of more prolonged therapy with moxifloxacin.
Two-month culture conversion rates are a well-accepted surrogate marker for the sterilizing activity of anti-tuberculosis drugs. Rifampin and pyrazinamide, the key drugs in current 6-month regimens, markedly increase 2-month culture-conversion rates. Therefore, this study will use 2-month culture conversion rate as the measure of antimicrobial activity of moxifloxacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRZE | Active comparator | Drug: isoniazidisoniazid, rifampin, pyrazinamide, ethambutol, moxifloxacin-placebo |
| MRZE | Experimental | Drug: Moxifloxacin (with rifampin, pyrazinamide, and ethambutol)moxifloxacin, rifampin, pyrazinamide, ethambutol, isoniazid-placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. Patients whose sputum cultures do not grow M. tuberculosis and those having an M. tuberculosis isolate resistant to (one or more) isoniazid, rifampin, fluoroquinolones, will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment. Sputum must be expectorated or induced; smear results from respiratory secretions obtained by bronchoalveolar lavage or bronchial wash may not be used for assessment of study eligibility.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment. HIV testing does not need to be repeated if there is written documentation of a positive test (positive ELISA and Western Blot or a plasma HIV-RNA level greater than 5000 copies/ml) at any time in the past.
- 7 (seven) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment.
- 7 (seven) or fewer days of fluoroquinolone therapy in the 3 months preceding enrollment.
- Age > 18 years
Key exclusion criteria (9 listed)
- Breast-feeding
- Known intolerance to any of the study drugs
- Known allergy to any fluoroquinolone antibiotic
- Concomitant disorders or conditions for which moxifloxacin (MXF), isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
- Current or planned therapy during the intensive phase of therapy using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy).
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 |
|---|---|---|
| Moxifloxacin (with rifampin, pyrazinamide, and ethambutol)Moxifloxacin 400mg daily, 8 weeks | Drug | MRZE |
| isoniazidisoniazid, oral, 300 mg, daily, 8 weeks | Drug | HRZE |
Primary outcome
• To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen
Time frame: 8 weeks
6 secondary outcomes
To compare the safety and tolerability of the moxifloxacin regimen to that of the isoniazid regimen
Time frame: 8 weeks
To determine the time to culture-conversion of the moxifloxacin regimen and the isoniazid regimen using data from 2-, 4-, 6-, and 8-week cultures
Time frame: 8 weeks
To compare the proportion of patients with any Grade 3 or 4 adverse reactions
Time frame: 8 weeks
To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients
Time frame: 8 weeks
To compare the rates of treatment failure of the moxifloxacin regimen and the isoniazid regimen
Time frame: 6 months
To determine whether there is delayed toxicity attributable to moxifloxacin (toxicity that becomes evident after the 8 weeks of moxifloxacin therapy)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
- Results publication: PubMed 19406981Dorman SE, Johnson JL, Goldberg S, Muzanye G, Padayatchi N, Bozeman L, Heilig CM, Bernardo J, Choudhri S, Grosset JH, Guy E, Guyadeen P, Leus MC, Maltas G, Menzies D, Nuermberger EL, Villarino M, Vernon A, Chaisson RE; Tuberculosis Trials Consortium. Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis. Am J Respir Crit Care Med. 2009 Aug 1;180(3):273-80. doi: 10.1164/rccm.200901-0078OC. Epub 2009 Apr 30.
- Derived from this study: PubMed 33542052Zhang N, Savic RM, Boeree MJ, Peloquin CA, Weiner M, Heinrich N, Bliven-Sizemore E, Phillips PPJ, Hoelscher M, Whitworth W, Morlock G, Posey J, Stout JE, Mac Kenzie W, Aarnoutse R, Dooley KE; Tuberculosis Trials Consortium (TBTC) and Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) Networks. Optimising pyrazinamide for the treatment of tuberculosis. Eur Respir J. 2021 Jul 20;58(1):2002013. doi: 10.1183/13993003.02013-2020. Print 2021 Jul.
- Derived from this study: PubMed 21494548Mac Kenzie WR, Heilig CM, Bozeman L, Johnson JL, Muzanye G, Dunbar D, Jost KC Jr, Diem L, Metchock B, Eisenach K, Dorman S, Goldberg S. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa. PLoS One. 2011 Apr 11;6(4):e18358. doi: 10.1371/journal.pone.0018358.
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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.
Richard E Chaisson, MD study chair
Johns Hopkins University
Susan E Dorman, MD principal investigator
Johns Hopkins University
John L Johnson, MD principal investigator
Case Western Reserve University
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxifloxacin (with rifampin, pyrazinamide, and ethambutol) and isoniazid in people with Tuberculosis, run by Centers for Disease Control and Prevention at 26 sites in 6 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 16 inclusion and 9 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: finished, as of the sponsor's last update on 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Brazil, South Africa, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen (time frame: 8 weeks). 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 NCT00144417, which also lists 3 linked publications.
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 3 Aug 2011.