Clinical trials: Multidrug-Resistant Bacterial Infections
Multi-drug Resistant Tuberculosis
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and…
- Trial name
- NCT03830671
- Testing
- 18-month regimen containing 6 anti-TB drugs
- Where
- 20 sites in China
- Volunteers
- 515 people
- Sponsor
- Beijing Chest Hospital
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic
Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options.
- Trial name
- TBCOX2 (NCT02503839)
- Testing
- etoricoxib, H56:IC31
- Where
- 2 sites in Norway
- Volunteers
- 39 people
- Sponsor
- Anne Margarita Dyrhol Riise
Tuberculosis, Drug-resistant Tuberculosis
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient
- Trial name
- NCT03266003
- Testing
- Electronic DOT, In-person DOT
- Where
- 4 sites in United States
- Volunteers
- 216 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Multidrug Resistant
Safety of RUTI® Vaccination in MDR-TB Patients
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to…
- Trial name
- NCT02711735
- Testing
- RUTI® Therapeutic vaccine
- Where
- 3 sites in Ukraine
- Volunteers
- 9 people
- Sponsor
- Archivel Farma S.L.
HIV Infection, MDR-TB
HIV and Multi-Drug Resistant Tuberculosis: a Study on Clinical Outcomes
This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran.
- Trial name
- NCT06671808
- Testing
- Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)
- Where
- Iran
- Volunteers
- 222,128 people
- Sponsor
- Zahedan University of Medical Sciences
Bacterial Contamination
The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms
The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).
- Trial name
- NCT04927806
- Testing
- Silver Knight
- Where
- Taiwan
- Volunteers
- 24 people
- Sponsor
- Fu Jen Catholic University
Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course…
- Conditions
- Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
- Trial name
- AHA-PLUS (NCT07393438)
- Testing
- Acetohydroxamic Acid
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Drug-resistant Tuberculosis
Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis
A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug…
- Trial name
- NCT06224036
- Testing
- JDB0131, Delamanid, Ethylpyrazine rifampicide (II)
- Where
- 2 sites in China
- Volunteers
- 52 people
- Sponsor
- Beijing Chest Hospital
Multidrug Resistant Gram Negative Bacterial Infections
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin
Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing of colistin based on its plasma levels in patients with infections due to multi-drug resistant gram negative bacilli.
- Trial name
- NCT01845246
- Testing
- Prospective TDM Arm of colistin
- Where
- 3 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Parc de Salut Mar
Tuberculosis Infection
Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis
Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their…
- Trial name
- SNAP (NCT02175849)
- Where
- Vietnam
- Volunteers
- 596 people
- Sponsor
- Oxford University Clinical Research Unit, Vietnam
Bacterial Infections, HIV Infections
Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs
The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs
- Trial name
- BMR-IST (NCT03767374)
- Testing
- Inguinal swab sample, Anal swab sample, Fecal sample
- Where
- France
- Volunteers
- 2,186 people, healthy volunteers welcome
- Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
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, Multidrug-Resistant
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens.
- Trial name
- Stake (NCT05555303)
- Testing
- Amikacin
- Where
- Rwanda
- Volunteers
- 20 people
- Sponsor
- Rwanda Biomedical Centre
Tuberculosis, Thoracic Surgery
Study of TB Lesions Obtained in Therapeutical Surgery
The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential…
- Conditions
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
- Trial name
- SH-TBL (NCT02715271)
- Testing
- therapeutical surgery for TB
- Where
- Georgia
- Volunteers
- 192 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Bacterial Infections, Mycobacterial Infection
- Trial name
- NCT04783727
- Testing
- Individualised treatment duration based on RNA transcriptomic model
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 4 people
- Sponsor
- Research Center Borstel
Tuberculosis
Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for Treating Patients With Multidrug-resistant TB and Patient With Both Multidrug-resistant TB and COVID-19
Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for treating patients with Multidrug-resistant TB and patient with both Multidrug-resistant TB…
- Trial name
- NCT05077813
- Testing
- 13 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB), 9 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB), All trans retinoic acid , Minocycline,Chicroic Acid and Vitamin D for (MDR-TB)
- Where
- 2 sites in Egypt, Saudi Arabia
- Volunteers
- 250 people
- Sponsor
- Kafrelsheikh University
Liver Cirrhosis
Efficacy of Vitamin C on AKI Outcomes in Critically Ill Cirrhotics With Multidrug-resistant Bacterial Infections.
In this prospective randomized controlled trial we aim to evaluate the impact of vitamin C on AKI outcomes in patients with cirrhosis and MDR infections.
- Trial name
- NCT04494451
- Testing
- Vit C, Standard medical Treatment
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Institute of Liver and Biliary Sciences, India