Clinical trials: Tuberculosis
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Treatment Adherence of Tuberculosis Medicines
It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions…
- Trial name
- TBAD (NCT01471977)
- Testing
- education,counseling, default tracers,quality of care
- Where
- Pakistan
- Volunteers
- 1,280 people
- Sponsor
- Gambat Institute of Medical Sciences
Tuberculosis
Clinical Study of BCG Vaccine for Intradermal Injection
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design. In this trial, 160 subjects were enrolled.
- Trial name
- NCT04563273
- Testing
- BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person）, BCG vaccine 3（0.075mg/0.1ml/person）
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Tuberculosis, Healthy
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in endemic areas and persons at…
- Trial name
- NCT00749034
- Testing
- VPM1002, BCG
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
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
- NCT02256839
- Testing
- CST_001
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
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, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Tuberculosis
Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa
Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis…
- Trial name
- NCT02391415
- Testing
- VPM1002, BCG, VPM1002(Hyg+)
- Where
- 4 sites in South Africa
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
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
Dovprela
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must…
- Trial name
- NCT06471088
- Testing
- Dovprela
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Viatris Inc.
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis (TB), Tuberculosis Vaccines
Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region.
- Trial name
- NCT00600782
- Testing
- GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)
- Where
- South Africa
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Infections, Human Immunodeficiency Virus and Tuberculosis
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
The current study is designed to confirm the mechanism behind the increase in serum creatinine observed during GSK1349572 therapy; specifically, the study will determine whether GSK1349572 has any effect on glomerular filtration…
- Trial name
- NCT01214993
- Testing
- GSK1349572, Iohexol Injection, Para-aminohippurate infusion
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Tuberculosis
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and…
- Trial name
- IIb-healthy (NCT02389322)
- Testing
- 5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10, BCG
- Where
- China
- Volunteers
- 1,044 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis, Pulmonary
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but…
- Trial name
- CONSTAN-ARG (NCT05455112)
- Testing
- RUTI® Vaccine
- Where
- 2 sites in Argentina
- Volunteers
- 41 people
- Sponsor
- Archivel Farma S.L.