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Expand New Drugs for TB [endTB] Observational Study

2017-08-23 18:23:21 | BioPortfolio

Summary

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

Study Design

Conditions

Tuberculosis, Multidrug-Resistant

Intervention

This is a non-intervention observational study

Location

National Treatment Centre for Tuberculosis, Abovian, Armenia
Abovyan
Armenia
220053

Status

Recruiting

Source

Partners in Health

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-08-23T18:23:21-0400

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Medical and Biotech [MESH] Definitions

Tuberculosis resistant to chemotherapy with two or more ANTITUBERCULAR AGENTS, including at least ISONIAZID and RIFAMPICIN. The problem of resistance is particularly troublesome in tuberculous OPPORTUNISTIC INFECTIONS associated with HIV INFECTIONS. It requires the use of second line drugs which are more toxic than the first line regimens. TB with isolates that have developed further resistance to at least three of the six classes of second line drugs is defined as EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS.

Tuberculosis resistant to ISONIAZID and RIFAMPIN and at least three of the six main classes of second-line drugs (AMINOGLYCOSIDES; polypeptide agents; FLUOROQUINOLONES; THIOAMIDES; CYCLOSERINE; and PARA-AMINOSALICYLIC ACID) as defined by the CDC.

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A study that uses observations at multiple time points before and after an intervention (the "interruption"), in an attempt to detect whether the intervention has had an effect significantly greater than any underlying trend over time.

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