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NCT ID: NCT02478463 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

Start date: February 27, 2017
Phase: Phase 1
Study type: Interventional

Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical sites associated with sexual HIV transmission following the proposed 600 milligram (mg) intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1 transmission and supplement the data to support future PrEP clinical trial development. The primary objective is to determine the PK concentrations of CAB following LA administration in plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a follow-up/withdrawal visit at Week 52 post-injection.

NCT ID: NCT02475915 Completed - Acute HIV Infection Clinical Trials

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion of patients between: Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral therapy (ART) Group 2: ART only who are able to maintain HIV RNA < 50 copies/ml following treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. The study will run for a minimum of 34 weeks from screening.

NCT ID: NCT02475733 Completed - Clinical trials for Complicated Intra-abdominal Infections

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

Start date: August 1, 2015
Phase: Phase 2
Study type: Interventional

This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam and metronidazole versus meropenem in paediatric population (from 3 months to less than 18 years of age )with complicated intra-abdominal infections (cIAIs)

NCT ID: NCT02474706 Terminated - Clinical trials for Urinary Tract Infections

Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli

COLIFOX
Start date: March 2016
Phase: Phase 4
Study type: Interventional

Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development. Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems. The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field. Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. Secondary objectives: - To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. - To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.

NCT ID: NCT02472886 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Start date: June 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.

NCT ID: NCT02469857 Completed - Clinical trials for Necrotizing Fasciitis

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

ACCUTE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

NCT ID: NCT02467712 Not yet recruiting - Fongal Infection Clinical Trials

Fungal Infection on a Joint Prosthesis

Start date: July 2015
Phase: N/A
Study type: Observational

It is generally accepted that the fungal infection on a joint prosthesis is to be treated in two surgical time: implant removal and prosthetic reconstruction. The service took the option for over 10 years to treat bacterial infections in joint replacement by a change in time. In four recent cases the diagnosis initially suspected of bacterial infection has been restated on intraoperative bacteriological examinations fungal infection. It is therefore a potentially harmful side effect of the chosen treatment option, but 4 patients in question were all cured of their fungal infection after a postoperative antifungal therapy. The objective of this study is to report these cases for discussion on the therapeutic choices in fungal infections on joint replacement.

NCT ID: NCT02467439 Completed - Clinical trials for Sexually Transmitted Infections

Acute Partner and Social Contact Referral: iKnow

Start date: June 2015
Phase: N/A
Study type: Interventional

The primary purpose of this research is to assess the benefit of an "unaware intervention package" for identifying high risk persons who are unaware of their HIV infection status. This intervention package includes screening for acute HIV infection, contract sexual partner referral, and peer referral.

NCT ID: NCT02464306 Withdrawn - Clinical trials for Clostridium Difficile Infection

Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

Start date: June 2018
Phase: Phase 4
Study type: Interventional

A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection (CDI).

NCT ID: NCT02463669 Terminated - Splenomegaly Clinical Trials

The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department

Start date: April 2016
Phase:
Study type: Observational

The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).