Clinical trials: Mycobacterium Infections
Lung Infection
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72…
- Trial name
- NCT00043355
- Testing
- interferon gamma-1b
- Volunteers
- 100 people
- Sponsor
- InterMune
Tuberculosis
Tuberculosis Vaccine in Healthy Indian Adults
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and…
- Trial name
- BBV169/2023 (NCT06438978)
- Testing
- Tuberculosis Vaccine
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Tuberculosis
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or…
- Trial name
- NCT05382312
- Testing
- GSK3036656, Bedaquiline, Delamanid
- Where
- South Africa
- Volunteers
- 127 people
- Sponsor
- GlaxoSmithKline
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
Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule.
- Trial name
- NCT01669096
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2.
- Trial name
- NCT05496374
- Testing
- SPR720 500 mg, SPR720 1000 mg
- Where
- 28 sites in United States
- Volunteers
- 25 people
- Sponsor
- Spero Therapeutics
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.
Systemic Lupus Erythematosus
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while…
- Trial name
- NCT07630714
- Testing
- Anifrolumab + APFS
- Where
- 32 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Tuberculosis, Pulmonary
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to…
- Trial name
- NCT04919239
- Testing
- RUTI®
- Where
- 2 sites in India
- Volunteers
- 140 people
- Sponsor
- Archivel Farma S.L.
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
- Trial name
- NCT00950612
- Testing
- GSK's investigational vaccine 692342
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 Study to Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing Potential
This study is designed to assess the pharmacokinetics (PK), safety, and tolerability of Ganfeborole and Microgynon, an oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG), when Microgynon is administered…
- Trial name
- NCT07784894
- Testing
- Ganfeborole, Microgynon
- Where
- Spain
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Assessing the Ability of the T-SPOT®.TB Test (IQ)
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease.
- Trial name
- IQ (NCT03973970)
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Oxford Immunotec
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by…
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT04922554
- Testing
- Omadacycline Oral Tablet
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Paratek Pharmaceuticals Inc
Mycobacterium Avium-intracellulare Infection, HIV Infections
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4…
- Trial name
- NCT00002267
- Testing
- Rifabutin
- Where
- 43 sites in United States, Canada
- Volunteers
- 750 people
- Sponsor
- Pharmacia
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Mycobacterium Infections, Nontuberculous
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection…
- Trial name
- CONVERT (NCT02344004)
- Testing
- LAI (Liposomal Amikacin for Inhalation) 590 mg
- Volunteers
- 336 people
- Sponsor
- Insmed Incorporated
Tuberculosis
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to…
- Trial name
- MTBVACN3 (NCT04975178)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 7,120 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Multiple Sclerosis, Relapsing Forms
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
- Trial name
- NCT01585766
- Testing
- MEDI-551 30 MG-IV, MEDI-551 60 MG-SC, MEDI-551 100 MG-IV
- Where
- 16 sites in United States, Poland and 2 more
- Volunteers
- 56 people
- Sponsor
- MedImmune LLC