NCT00948077

Brief Summary

The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

June 16, 2009

Last Update Submit

April 11, 2011

Conditions

Pulmonary Tuberculosis

Keywords

tuberculosispharmacokineticfirst-line drugs

Outcome Measures

Primary Outcomes (1)

  • The maximum concentration (Cmax)of first-line TB drugs

    Before and 1, 2, 4, 6 and 10 hours after dosing

Secondary Outcomes (1)

  • N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.

    Before taking the anti-TB drugs on the fifth day

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."

Drug: Rifater and EMB

Treatment B

EXPERIMENTAL

Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."

Drug: Rifater and EMB

Interventions

Rifater and EMBDRUG

The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---\> Treatment B (6th day) ; Treatment B (5th day) ---\> Treatment A (6th day)

Treatment ATreatment B

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 20 years
  • Karnofsky score of \> 50
  • Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
  • A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
  • Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
  • Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
  • Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
  • The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
  • Only subjects who have provided signed and dated written informed consent will be included.

You may not qualify if:

  • Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
  • Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
  • Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
  • Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
  • Women who are Pregnant or breastfeeding during the study period.
  • Subjects with a known allergy to study drugs
  • In the opinion of the investigator to be unsuitable for study participation for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University- Wan Fang Hospital

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Tuberculosis, PulmonaryTuberculosis

Interventions

isoniazid, pyrazinamide, rifampin drug combination

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ming-Chih MC Yu, M.D.

    Taipei Medical University- Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih MC Yu, M.D.

CONTACT

+886-2-29307930yutbc@ms10.hinet.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

July 29, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations

TW(1)