Evaluation of alternative bacteriological measures of response to therapy during the initial 16-weeks of MDR-TB (drug resistant tuberculosis) treatment

Alternative measures of response to MDR-TB treatment

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN45714844

Enrollment

Registered

2021-04-23

Start date

2020-02-12

Completion date

Unknown

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alternative measures of response to MDR-TB (drug-resistant tuberculosis) therapy Infections and Infestations

Interventions

A prospective study of 59 patients’ = 18 years of age with MDR-TB diagnosed according to local standards will be enrolled into the study. Two sputum samples, a spot, and an overnight will be taken at

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults >18 years of age 2. Have a productive cough 3. Sputum specimens that are positive for acid fast bacilli by microscopy (1+ to 3+, smear-positive) 4. Have been classified as MDR TB

Exclusion criteria

Exclusion criteria: 1. Prisoners 2. Subjects <18 years of age 3. Patients who are unable to provide =3mL of sputum specimen for testing 4. Patients on anti-TB treatment

Design outcomes

Primary

Measure	Time frame
Sputum bacterial load burden, measured using Culture colony forming units (CFUs) as a reference standard, with MGIT time to positivity, Xpert PMA, FDA, Smear Microscopy, and TB-MBLA measured at weeks 0, 2, 4, 6, 8, 12 and 16	—

Secondary

Measure	Time frame
1. Patient clinical characteristics will be collected using a detailed data collection tool at baseline (week 0) 2. Baseline resistance profiles will be collected from the existing patient records at the clinic and tested using phenotypic drug susceptibility testing (DST) whenever possible 3. Adherence measured using available clinical data and as collected by the study nurse during MDR-TB treatment 4. HIV-status will be collected as documented in the clinic patient records at baseline	—

Measure

Time frame

1. Patient clinical characteristics will be collected using a detailed data collection tool at baseline (week 0) 2. Baseline resistance profiles will be collected from the existing patient records at the clinic and tested using phenotypic drug susceptibility testing (DST) whenever possible 3. Adherence measured using available clinical data and as collected by the study nurse during MDR-TB treatment 4. HIV-status will be collected as documented in the clinic patient records at baseline

—

Countries

Uganda

Contacts

Public ContactWilly Ssengooba

willy.ssengooba@mak.ac.ug+256702411840

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026