Phase 3 N=364 Treatment of Latent TB Infection for Jailed Persons
Tuberculosis
Primary: Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication — 6; 3 participants — p=>.05
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=1,978 Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
Latent Tuberculosis Infection
Primary: TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. — 2; 37; 20 participants
N/A N=322 Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Latent Tuberculosis Infection
Primary: Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea — 57 number of new cases per 1000 person/year
Phase 3 N=8,053 Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
Tuberculosis
Primary: Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18…
Early Phase 1 N=17 Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Healthy · Latent Tuberculosis Infection (LTBI)
Primary: Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD) — 5.26; 0.725; 29.9; 2.92 % Antigen Specific T…
Phase 2 N=96 Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Tuberculosis · AIDS-related Complex
Primary: Sputum Conversion — 36; 60; 36 percentage of participants
Phase 2 N=300 Infant TB Infection Prevention Study
Tuberculosis
Primary: Mycobacterium Tuberculosis (MTB) Infection — 10; 18 participants
Phase 1 N=25 Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
Latent Tuberculosis · Latent Tuberculosis Bacteriology and Histology Unknown
Primary: Number of Participants With at Least One Adverse Event (AE) Through Day 210 — 8; 8; 9; 6 Participants
Phase 3 N=3,000 Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
Tuberculosis · HIV Infections
Primary: Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause — 0.6506; 0.6736 Events per 100 person-years
N/A N=25 Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
Latent Tuberculosis
Primary: Feasibility: Participant Attendance — 10; 9; 7; 8 participants
Phase 3 N=394 Tuberculosis Treatment Shortening Trial
Tuberculosis
Primary: Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat — 13; 3 Participants
Phase 2 N=50 Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women
Tuberculosis
Primary: Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK — 1.4; 1.50 L/hr
Phase 2 N=70 Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
Tuberculosis
Primary: Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) — 0.98; 0.98; 0.96; 0.95 Percentage — p=<0.001
Phase 2 N=546 Using Biomarkers to Predict TB Treatment Duration
Pulmonary Tuberculosis
Primary: Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C — 217; 121; 117; 5 Participants
Phase 3 N=2,516 TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
Tuberculosis
Primary: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3…
Phase 4 N=1,995 Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Tuberculosis · HIV Infections
Primary: Number of Participants With Incident Tuberculosis — 20; 34 Participants
N/A N=490 Tuberculosis Research of INA-RESPOND On Drug Resistance
Lung Tuberculosis · MDR TB
Primary: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases — 23; 64 Participants
Phase 4 N=956 Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
HIV Infections · Tuberculosis
Primary: Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment — 15.03; 14.93 events per…
Phase 2 N=69 Essentiality of INH in TB Therapy
Tuberculosis
Primary: Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14 — 0.134; 0.096; 0.136; 0.119…
Phase 2 N=98 A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
Latent Tuberculosis Bacteriology and Histology Unknown · Latent Tuberculosis
Primary: Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination. — 7; 8; 15; 15 Participants
N/A N=66 Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Tuberculosis
Primary: Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites — 32; 23 Participants
Phase 3 N=1,002 Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
Latent Tuberculosis Infection
Primary: Treatment Completion Rate. — 294; 248; 250 Participants
Phase 2 N=144 Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Tuberculosis
Primary: Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10 — 13; 13; 14; 13 participants
Phase 1 N=11 Doravirine, Rifapentine and Isoniazid Interaction
Latent Tuberculosis · Human Immunodeficiency Virus · Rifamycins Causing Adverse Effects in Therapeutic Use
Primary: Doravirine Maximum Concentration (Cmax) — 1.7; 1.3 ug/mL
Phase 3 N=588 The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
MDR-TB
Primary: STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) — 0; 133; 162; 122 Participants
Phase 2 N=282 High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Tuberculosis
Primary: Daily Change in log10 Colony-forming Unit (CFU) — -0.06; -0.18; -0.21; -0.15 log10 CFU per mL sputum per day
Phase 2 N=41 Linezolid to Treat Extensively-Drug Resistant Tuberculosis
Pulmonary Tuberculosis · Multidrug Resistant Tuberculosis · Extensively Drug Resistant Tuberculosis
Primary: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. — 15; 7 participants
Phase 2 N=76 An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis
Primary: Change in log10 Colony Forming Units (CFU) Per (/) Milliliter (mL) of Direct Respiratory Sputum Samples From Baseline to Day 14 — -0.199; -0.017; -0.092; -0.092…
Phase 2 N=68 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
Pulmonary Tuberculosis
Primary: Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time…
Phase 4 N=500 Ultra Curto (Ultra Short) TB Prevention Therapy
Tuberculosis
Primary: Number of Participants Who Complete Treatment With >90% Adherence — 223; 211 Participants — p=0.07