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Communicable Diseases clinical trials

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NCT ID: NCT03236987 Recruiting - Lung Infection Clinical Trials

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

CLAZI
Start date: February 5, 2018
Phase: Phase 3
Study type: Interventional

MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for the treatment of these non-tuberculous mycobacterial infections recommend the use of a macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and ethambutol. For MAC disseminated infections, several studies have compared combinations containing clarithromycin or azithromycin and found no significant difference in efficacy. No randomized controlled trials have been performed for pulmonary infections to compare clarithromycin and azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450 . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis. Azithromycin has fewer side effects especially less digestive toxicity and drug interactions than clarithromycin. The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in comparison with that of clarithromycin.

NCT ID: NCT03235947 Completed - Clinical trials for Urinary Tract Infection

Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

PERIFOS
Start date: September 7, 2016
Phase: Phase 4
Study type: Interventional

A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate.

NCT ID: NCT03235635 Recruiting - Clinical trials for Microbial Colonization

Metagenomic Analysis of Gut Microbiome in Preterm

MAGMP
Start date: July 25, 2017
Phase: N/A
Study type: Observational

This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

NCT ID: NCT03234036 Completed - HIV Infections Clinical Trials

A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir

Start date: August 2, 2017
Phase: Phase 1
Study type: Interventional

This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232. Part 1 of the study will assess single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing approximately 30% fat) against the reference capsule formulation also given with food and then will assess the impact of fasted conditions on the tablet performance. In Part 2, non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate group of subjects, assuming the tablet performance is considered acceptable from Part 1. Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at least 8 evaluable subjects through the single study period in Part 2. The maximum duration of study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part 2.

NCT ID: NCT03233438 Completed - Clinical trials for Bacterial Infections

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Start date: July 24, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

NCT ID: NCT03232242 Recruiting - Infectious Disease Clinical Trials

Application of NGS Technique in Precise Diagnosis of Infectious Diseases

Start date: August 1, 2017
Phase: N/A
Study type: Observational

Infectious disease leads to deaths that accounted for more than 25% of all causes of human mortality. But the traditional microbiological diagnostic methods such as specimen culture are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and viruses may be difficult to cultivate and isolation. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment. Small-scale studies on the diagnostic efficacy and prognosis of infection in the next generation have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but the larger-scale validation of next-generation sequencing Technology in the diagnosis and treatment of infectious diseases in the human body is relatively rare. The purpose of this study is to provide rapid etiological diagnosis of patients by means of next-generation sequencing, to change the way of treatment of patients under the existing traditional pathogen detection by means of accurate description of pathogens and monitoring their dynamic changes, and to provide patients with more accurate treatment.

NCT ID: NCT03231943 Completed - HIV Infections Clinical Trials

GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers

Start date: September 19, 2017
Phase: Phase 1
Study type: Interventional

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.

NCT ID: NCT03230916 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.

NCT ID: NCT03230838 Completed - Pyelonephritis Clinical Trials

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Start date: April 26, 2018
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

NCT ID: NCT03229863 Active, not recruiting - Clinical trials for Microbial Colonization

An Examination of Infants' Microbiome, Nutrition, and Development Study.

IMiND
Start date: April 18, 2017
Phase: N/A
Study type: Interventional

This study is examining the relationship between infant nutrition, gut health, and development. The fecal microbiota changes and develops, in large part due to the food that infants eat. These changes are important for many aspects of development. This study is designed to examine how the fecal microbiota changes when exclusively breastfed infants are first introduced to solid food, and how changes of the fecal microbiota are related to other aspects of development.