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Communicable Diseases clinical trials

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NCT ID: NCT02486406 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

ZIRCON
Start date: October 28, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

NCT ID: NCT02483715 Completed - Clinical trials for Helicobacter Pylori Infection

Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

Start date: July 2015
Phase: Phase 4
Study type: Interventional

Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication. The aims of this study are: 1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

NCT ID: NCT02482961 Completed - Clinical trials for Acinetobacter Infections

Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection

Start date: May 2015
Phase:
Study type: Observational

This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.

NCT ID: NCT02482636 Completed - Infectious Diseases Clinical Trials

Baby Vaccine Study (Sched3)

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

This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will provide information about how best to include the meningococcal B vaccine (likely to be introduced late 2015) into the routine immunisation schedule. The UK Department of Health provides a routine vaccination schedule for children in the UK and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the current MenC conjugate vaccine dose given at 3 months of age. There is no published immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme. This change to the schedule would result in three injections at 2, 4 and 12 months, and given previous reluctance among parents for three injections at one visit, an option to reduce PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed in this study.

NCT ID: NCT02479347 Completed - Breast Neoplasms Clinical Trials

Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine

Start date: March 2013
Phase: Phase 4
Study type: Interventional

The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site, since the patient's skin is the principal source of bacterial contamination of the wound. This study aims to investigate the efficacy in prevention of surgical site infection in clean surgery, using two different standardized methods of skin preparation: povidone-iodine 10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a single-center study will enroll a homogeneous population, undergoing breast cancer surgery.

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: 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.