CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 262 enrolled
Drug / intervention
Treatment +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02371681
NCT02371681Phase 2Completed

NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 26, 2015·Updated Jun 18, 2023

In Brief

A Phase 2 clinical trial evaluating Treatment, PET/CT Scan, and 1 other intervention for Pulmonary Tuberculosis. Completed, enrolled 262 participants across 2 sites.

Detailed Summary

Background: \- Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they may spread these bacteria. Researchers are looking for new TB medicines. They want to find a faster way to tell if a drug might combat TB. Objective: \- To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB. Eligibility: \- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines. Design: * Participants will be admitted to the hospital for screening. They will have medical history, physical exam, and chest radiograph. They will give blood, urine, and sputum samples. * Participants will be put in 1 of 8 groups. * Participants will get one or a combination of TB medicines daily for about 14 days. * Each day, participants: * Will discuss side effects. * May have a physical exam. * Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make them cough. * Participants will have blood taken 3-4 times during the study * Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure TB disease in the lungs. It will be injected into a vein. Participants will lie in a scanner that takes pictures. * Around study day 14, participants will leave the hospital. They will be referred to a local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will already be on these medicines and will have another FDG-PET/CT on day 28. * Participants will be in the study for up to 28 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 26, 2015
Enrollment StartFeb 25, 2015
Primary CompletionSep 1, 2017
Study CompletionNov 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.3 years ago

Interventions

Treatmentdrug

Different Drug combinations

PET/CT Scanradiation

PET/CT Scans

Sample Collectionprocedure

Sample Collection