TuberculosisPhase 4NCT00397709
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
A Phase 4 study testing I ( isoniazid), II (isoniazid + rifampin ) in people with Tuberculosis, run by Hospital Virgen de la Luz at 1 site in Spain.
Trial summary
The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with… Read more about this study
- Who is it for?
- Ages 16 to 89 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- I ( isoniazid), II (isoniazid + rifampin )
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- Mar 1996to Feb 2006
- 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 16 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:
Who cannot join
- HIV infection.
- Hepatopathy
- Previous treatment of of latent tuberculosis infection.
- Allergy to drugs.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Maria Paloma Geijo Martinez. Hospital Virgen de la Luz
Cuenca, Cuenca, 16002
About this study
Official title: Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.
The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.
Read the detailed description
Introduction: The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months with the standard course for 6 months.
Methods: Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. the group I was assigned to isoniazid (H) at a dose of 300 mg per day for 6 months and the group II was assigned to isoniazid at a dose of 300 mg per day plus rifampin (R) (600 mg per day) for 3 months. The patients were followed for five years.
Results: 105 patients were included, of which 9 refused the treatment; 45 patients were included in the group I and 51 patients in the group II. Both groups were comparable at base level. The hepatotoxicity was 44% in the group 6H and 29% in the group 3HR (p = 0,07). The hepatotoxicity was severe in 6.7% in the group 6H and 5.8% in the group 3HR; these obliged the suspension of treatment in 4.4% and 1.9%, respectively (p =NS). The proportion of patients who completed the study treatment was 75.6% of the patients in the group 6H, and 90.2% in the group 3HR (p = 0,05). Only a case of tuberculosis was detected in the second month treatment with 6H.
Conclusion: In the treatment of latent tuberculosis infection, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.
- Conditions
- Tuberculosis
- Being tested
- I ( isoniazid), II (isoniazid + rifampin )
- Keywords
- Latent tuberculosis infection., Isoniazid., Rifampin., Clinical trial., treatment of latent tuberculosis infection
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I ( isoniazid), II (isoniazid + rifampin )Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the compliance
to compare the side effects
Secondary outcomes (1)
Development of tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startMar 1996
- Study completionFeb 2006
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
- 228 participants
Sponsor and investigators
- Lead sponsor
- Hospital Virgen de la Luz
- Sponsor type
- University, hospital or other
- Investigators
- Maria Paloma Geijo Martinez, MD, Principal investigator, Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397709
- Sponsor's protocol ID
- TBQXCU2
- Other IDs
- TBQXPNCU1
- Status last verified
- Nov 2006
- First submitted
- 7 Nov 2006
- Last updated
- 31 Dec 2008
- Results posted
- No
Publications
Geijo MP, Herranz CR, Vano D, Garcia AJ, Garcia M, Dimas JF. [Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: a randomized clinical trial]. Enferm Infecc Microbiol Clin. 2007 May;25(5):300-4. doi: 10.1157/13102264. Spanish.
PubMed 17504682
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00397709
- Acronym / sponsor ID
- TBQXCU2
- Conditions
- Tuberculosis
- Keywords
- Latent tuberculosis infection., Isoniazid., Rifampin., Clinical trial., treatment of latent tuberculosis infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 228 participants
- Lead sponsor
- Hospital Virgen de la LuzUniversity, hospital or other
- Study start
- Mar 1996
- Study completion
- Feb 2006
- First posted
- 9 Nov 2006 (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 objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.
Detailed description
Introduction: The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months with the standard course for 6 months.
Methods: Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. the group I was assigned to isoniazid (H) at a dose of 300 mg per day for 6 months and the group II was assigned to isoniazid at a dose of 300 mg per day plus rifampin (R) (600 mg per day) for 3 months. The patients were followed for five years.
Results: 105 patients were included, of which 9 refused the treatment; 45 patients were included in the group I and 51 patients in the group II. Both groups were comparable at base level. The hepatotoxicity was 44% in the group 6H and 29% in the group 3HR (p = 0,07). The hepatotoxicity was severe in 6.7% in the group 6H and 5.8% in the group 3HR; these obliged the suspension of treatment in 4.4% and 1.9%, respectively (p =NS). The proportion of patients who completed the study treatment was 75.6% of the patients in the group 6H, and 90.2% in the group 3HR (p = 0,05). Only a case of tuberculosis was detected in the second month treatment with 6H.
Conclusion: In the treatment of latent tuberculosis infection, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:
Key exclusion criteria (4 listed)
- HIV infection.
- Hepatopathy
- Previous treatment of of latent tuberculosis infection.
- Allergy to drugs.
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 |
|---|---|---|
| I ( isoniazid), II (isoniazid + rifampin ) | Drug | – |
Primary outcome
to compare the compliance
to compare the side effects
1 secondary outcome
Development of tuberculosis
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Derived from this study: PubMed 17504682Geijo MP, Herranz CR, Vano D, Garcia AJ, Garcia M, Dimas JF. [Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: a randomized clinical trial]. Enferm Infecc Microbiol Clin. 2007 May;25(5):300-4. doi: 10.1157/13102264. Spanish.
- Page of infectious diseases of the region with studies on TBLink provided by the sponsor.
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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.
Maria Paloma Geijo Martinez, MD principal investigator
Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing I ( isoniazid), II (isoniazid + rifampin ) in people with Tuberculosis, run by Hospital Virgen de la Luz at 1 site in Spain.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study was stopped early. Results are not available in the source record.
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 compliance. 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 NCT00397709, 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 31 Dec 2008.