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Infections clinical trials

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NCT ID: NCT03610581 Terminated - Clinical trials for Human Papillomavirus Infections

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

Start date: September 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

NCT ID: NCT03605758 Terminated - Strongyloidiasis Clinical Trials

Treatment of Strongyloides Infection

TSSI
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.

NCT ID: NCT03597347 Terminated - Clinical trials for Mycobacterium Infections, Nontuberculous

Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection

ENCORE
Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

NCT ID: NCT03596697 Completed - Hepatitis B Clinical Trials

A Study in Healthy Volunteers

Start date: July 9, 2019
Phase: Phase 1
Study type: Interventional

This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

NCT ID: NCT03595566 Completed - Clinical trials for Clostridioides Difficile Infection

To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 2
Start date: January 28, 2019
Phase: Phase 3
Study type: Interventional

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

NCT ID: NCT03595553 Completed - Clinical trials for Clostridioides Difficile Infection

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 1
Start date: January 28, 2019
Phase: Phase 3
Study type: Interventional

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.

NCT ID: NCT03594981 Recruiting - Viral Infection Clinical Trials

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

Start date: January 24, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.

NCT ID: NCT03583164 Recruiting - Clinical trials for Invasive Fungal Infections

Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

FORMULA-OLS
Start date: June 6, 2018
Phase: Phase 2
Study type: Interventional

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

NCT ID: NCT03580044 Terminated - Clinical trials for Serious Bacterial Infection

Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria

Start date: December 25, 2020
Phase: Phase 3
Study type: Interventional

Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) and ventilator associated pneumonia (VAP), complicated urinary tract infections (cUTI), or bloodstream infections (BSI) due to metallo-β-lactamase (MBL)- producing Gram-negative bacteria.

NCT ID: NCT03574090 Completed - Clinical trials for Surgical Wound Infection

Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

PROTOP
Start date: October 20, 2020
Phase: Phase 4
Study type: Interventional

The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery