Condition category
Infections and Infestations
Date applied
07/04/2005
Date assigned
07/06/2005
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr T Kanyok

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
kanyokt@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC078

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tuberculosis (TB)

Intervention

Control
Regimen 1: Standard TB treatment (isoniazid, rifampicin, pyrazinamide and ethambutol)

Interventions
Regimen 2: Isoniazid, rifampicin, pyrazinamide and gatifloxacin
Regimen 3: Isoniazid, rifampicin, pyrazinamide and ofloxacin
Regimen 4: Isoniazid, rifampicin, pyrazinamide and moxifloxacin

Intervention type

Drug

Phase

Not Specified

Drug names

Gatifloxacin, moxifloxacin and ofloxacin, ethambutol, rifampicin, isoniazid and pyrazinamide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/11/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male/female of 18-65 years
2. Weight 38-80 kg
3. Recently microscopically diagnosed pulmonary TB
4. Findings in medical history and physical examination not exceeding grade 2
5. Voluntarily signed informed consent
6. Confirmed negative pregnancy test at the screening visit
7. Willing to use effective contraceptive methods during treatment
8. Normal lab values not exceeding grade 2, except haemoglobin <6.5 g/dl and potassium <3.0 mEq/l (>grade 1)
9. Consent for a pre-screening biological test to exclude possible Multi Drug Resistant (MDR) TB and Negative MDR TB screen test will be a check if pre-screening biological test is done

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. History of TB within the last 3 years
2. Concomitant infection requiring additional anti-infectious treatment (especially anti-retroviral medication [ARV])
3. Human immunodeficiency virus (HIV) infected patients at World Health Organisation (WHO) stage 4
4. Diabetes mellitus or non insulin dependent diabetes mellitus requiring treatment
5. Drug and alcohol abuse
6. History of drug hypersensitivity and/or active allergic disease
7. Impaired renal, hepatic or gastric function that may interfere with drug absorption, distribution, metabolism or elimination

Recruitment start date

25/11/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

South Africa

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Other

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes