The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01182259
Recruitment Status : Unknown
Verified August 2010 by E-DA Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2010
Last Update Posted : August 16, 2010
Information provided by:
E-DA Hospital

Brief Summary:

Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.

The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.

Condition or disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed TB patient in E-DA hospital

Inclusion Criteria:

  1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
  2. No previous anti-TB drugs treatment
  3. Age more than 18years old

Exclusion Criteria:

  1. Expected life < 6months
  2. Baseline AST and ALT > 3 fold upper limit of normal (ULN) or total bilirubin>2mg/dl
  3. Age less than 18years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01182259

Contact: Jiun-Ting Wu, MD 886-7-615-0011 ext 2980

E-DA hospital Recruiting
Kaohsiung, Taiwan
Contact: Chien-Tung Chiu    886-7-615-0011 ext 2980   
Principal Investigator: Yuan-Kun Tu, MD         
Sponsors and Collaborators
E-DA Hospital Identifier: NCT01182259     History of Changes
Other Study ID Numbers: JTWu002
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections