NCT00082173

Brief Summary

Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

April 30, 2004

Results QC Date

March 26, 2013

Last Update Submit

March 26, 2013

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With Sterile Sputum Cultures

    Proportion of patients with sterile sputum cultures

    8 weeks

Secondary Outcomes (1)

  • Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks

Drug: Moxifloxacin

2

PLACEBO COMPARATOR

INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks

Drug: Moxifloxacin

Interventions

MoxifloxacinDRUG

400mg daily for 8 weeks

Also known as: Avelox
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible.
  • Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation.
  • Agree to use acceptable methods of contraception

You may not qualify if:

  • History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB
  • Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated
  • History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever
  • Active AIDS-related opportunistic infection or malignancy
  • Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry
  • Silicotuberculosis
  • Central nervous system TB
  • Pregnant or breastfeeding
  • Unable to take oral medication
  • Electrocardiogram (EKG) QTc interval greater than 450 msec
  • Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant
  • Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clementino Fraga Filho Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (1)

  • Conde MB, Efron A, Loredo C, De Souza GR, Graca NP, Cezar MC, Ram M, Chaudhary MA, Bishai WR, Kritski AL, Chaisson RE. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet. 2009 Apr 4;373(9670):1183-9. doi: 10.1016/S0140-6736(09)60333-0.

    PMID: 19345831DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Richard Chaisson
Organization
Johns Hopkins University
rchaiss@jhmi.edu
410-955-1755

Study Officials

  • Richard E. Chaisson, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2004

First Posted

May 4, 2004

Study Start

October 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2008

Last Updated

May 22, 2013

Results First Posted

May 22, 2013

Record last verified: 2013-03

Locations

BR(1)