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OpenTrials
Completed

NCT Number: NCT00810407

Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Non-tuberculous Mycobacterial Diseases (Including MAC Disease)

Sex eligibility

All sexes

Study type

Observational

About this study

All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion criteria

  • Patients not administered Mycobutin®.

Treatment and study plan

rifabutin

Drug

Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " 1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily.

2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily".

Other names: Mycobutin.

Primary outcomes

  1. Number of Participants With Treatment-Related Adverse Events

    Time frame: 1 year

    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator.

  2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

    Time frame: 1 year

    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator.

  3. Number of Participants With Treatment-Related Adverse Events by Diagnosis

    Time frame: 1 year

    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.

  4. Number of Participants With Treatment-Related Adverse Events by Gender

    Time frame: 1 year

    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.

  5. Number of Participants With Treatment-Related Adverse Events by Age

    Time frame: 1 year

    A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.

  6. Clinical Efficacy Rate

    Time frame: 1 year

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values.

  7. Clinical Efficacy Rate by Diagnosis

    Time frame: 1 year

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness.

  8. Clinical Efficacy Rate by Gender

    Time frame: 1 year

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness.

  9. Clinical Efficacy Rate by Age

    Time frame: 1 year

    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as "effective," "ineffective," or "unassessable" by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Dec 18, 2008
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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