Clinical trials: Mycobacterium Infection
Human Immunodeficiency Virus, Tuberculosis
Usability Study of IeHS in Indonesia
Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health.
- Conditions
- Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations, Mobile Phone Use
- Trial name
- NCT04179344
- Testing
- Integrated e-healthcare services (IeHS) web-based app
- Where
- 3 sites in Indonesia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bekasi City Public Hospital
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.
Tuberculosis Infection
Equivalence Study of Specificity of PPD
Determine if investigational products and reference standard produce similar responses.
- Trial name
- 03 (NCT01798095)
- Testing
- Aplisol@ PPD material, Reference Standard
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- JHP Pharmaceuticals LLC
Leprosy
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022.
- Trial name
- BE-PEOPLE P2 (NCT05406479)
- Testing
- BE-PEP (Bedaquiline), SDR-PEP, BE-PEP (Rifampicine)
- Where
- Comoros
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis, Latent Tuberculosis
The Epidemiology of TST Change in Korea
TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.
- Trial name
- NCT01850043
- Where
- South Korea
- Volunteers
- 5,552 people, healthy volunteers welcome
- Sponsor
- Asan Medical Center
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Mycobacterium Infections
Study of Mycobacterial Infections
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections.
- Trial name
- NCT00018044
- Testing
- Clofazimine
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis Infection, Tuberculosis Prevention
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts…
- Trial name
- NCT04494516
- Where
- 2 sites in Ethiopia, South Africa
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA
Tuberculosis, Latent Tuberculosis
Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for…
- Trial name
- PREDICT (NCT01162265)
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Public Health England
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Latent Tuberculosis
Latent Tuberculosis Infection in Korean Health Care Workers
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.
- Trial name
- NCT03010111
- Testing
- QFT-IT Test and other blood sampling
- Where
- South Korea
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Hanyang University
Leprosy
Leprosy Skin Test Antigens Phase 1
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae.
- Trial name
- NCT01920750
- Testing
- MLCwA, MLSA-LAM, Mock Antigen
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, BCG Vaccination
Clinical Study to Evaluate Safety and Immunogenicity of Bacillus Calmette-Guerin (BCG) Delivery Via Novel Micronjet600 Device Compared to Those Via Conventional Needle
The purpose of this study is to evaluate safety and immunogenicity of Bacillus Calmette-Guerin (BCG) delivery via Novel Micronjet600 device compared to those via conventional needle.
- Trial name
- NCT04064554
- Testing
- BCG vaccination with MicronJet600, BCG vaccination with conventional needle
- Where
- South Korea
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Tuberculosis
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824.
- Trial name
- CL-009 (NCT01830439)
- Testing
- PA-824 200mg, PA-824 50mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
- Trial name
- NCT01497769
- Testing
- Aerosol inhaled MVA85A, Intradermal MVA85A
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis
Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety…
- Trial name
- NCT06305104
- Testing
- 2.5μg/ml EEC, 5μg/ml EEC, 5 unit（U） EC
- Where
- 6 sites in China
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd