Clinical trials: tuberculosis
TUBERCULOSIS, PULMONARY
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
- Trial name
- ISIT-TB (NCT04995406)
- Testing
- ISIT-TB prototype
- Where
- South Africa
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Tuberculosis
Evaluation of Efficacy and Safety of the Concomitant of RUTI® Immunotherapy With the Standard Treatment in TB Patients
The study is an exploratory clinical trial to evaluate the efficacy and safety of the treatment with a vaccine against tuberculosis (RUTI®) given at the same time as standard treatment in patients with tuberculosis.
- Trial name
- CONSTAN (NCT05136833)
- Testing
- RUTI® vaccine
- Sponsor
- Archivel Farma S.L.
Infections and Infestations, Pulmonary Tuberculosis
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose…
- Trial name
- DECODE (NCT04550832)
- Testing
- Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
- Where
- 5 sites in South Africa, Tanzania
- Volunteers
- 76 people
- Sponsor
- LigaChem Biosciences, Inc.
Tuberculosis
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection…
- Trial name
- NCT05284812
- Testing
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB.
- Trial name
- NCT01587469
- Where
- United States
- Volunteers
- 992 people
- Sponsor
- Cepheid
Pulmonary Tuberculosis
Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis
- Trial name
- NCT02467608
- Testing
- Isoniazid with HUEXC030 and RZE, HRZE
- Where
- 18 sites in Taiwan
- Volunteers
- 557 people
- Sponsor
- Orient Pharma Co., Ltd.
Healthy Volunteers
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832.
- Trial name
- NCT07542847
- Testing
- OPC-167832, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
BCG Vaccination Reaction, Tuberculosis
A Study of GC3107(BCG Vaccine) in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
- Trial name
- NCT03947138
- Testing
- GC3107, Intradermal BCG SSI inj.
- Where
- 2 sites in South Korea
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Tuberculosis
Phase I Clinical Protocol of BCG-PPD in Healthy People
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected…
- Trial name
- NCT04593771
- Testing
- BCG-PPD
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double…
- Trial name
- NCT04239313
- Testing
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis, Tuberculosis Vaccines
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo.
- Trial name
- NCT01755598
- Testing
- GSK Biologicals' investigational TB vaccine (GSK692342)
- Where
- 9 sites in Kenya, South Africa and 1 more
- Volunteers
- 3,575 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Phase 2a Study of PBTZ169
Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed…
- Trial name
- NCT03334734
- Testing
- PBTZ169, Isoniazid
- Volunteers
- 16 people
- Sponsor
- Nearmedic Plus LLC
Pulmonary Multi-drug Resistant Tuberculosis
A Prospective Patient Registry of Patients Exposed to Bedaquiline
The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations…
- Trial name
- NCT02274389
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Janssen Research & Development, LLC
Latent Tuberculosis Infection, Tuberculosis
Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection
The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.
- Trial name
- NCT01136161
- Testing
- RUTI
- Where
- 3 sites in South Africa
- Volunteers
- 95 people
- Sponsor
- Archivel Farma S.L.
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02253537
- Testing
- CST001
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on…
- Trial name
- NCT06354257
- Testing
- Microgynon, GSK3036656
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection
- Trial name
- NCT04685720
- Testing
- LungFit
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Beyond Air Inc.
Tuberculosis
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days.
- Trial name
- NCT00990990
- Testing
- PNU-100480, Linezolid
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Sequella, Inc.
Healthy Volunteers
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if…
- Trial name
- NCT00925535
- Testing
- Lersivirine, Rifabutin
- Where
- Singapore
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer