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Communicable Diseases clinical trials

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NCT ID: NCT01853540 Completed - Clinical trials for Nontuberculous Mycobacterial Infection

Sildenafil for PNTM Infection

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of bacteria in the environment. Although PNTM infection is most common in people with lung diseases, it can also affect healthy people. It can be difficult to treat, and affects parts of the body other than the lungs. For example, PNTM may affect the cilia, the hair-like structures inside the nose and lungs that help move dirt and debris out of the body. - Ciliary beat frequency (CBF) is a measurement of how fast cilia move. People with PNTM infection have a lower CBF than healthy people. Nitric oxide (NO) is a gas in the body that may affect CBF. People with PNTM infection produce lower amounts of NO in their noses than healthy people. Researchers want to see if a drug called sildenafil can increase NO production and CBF. If sildenafil can improve these measurements, it may be a useful treatment for PNTM infection. Objectives: - To study the effect of sildenafil on CBF and NO levels in people with PNTM infection. Eligibility: - Individuals at least 18 years of age who have PNTM infection. - Participants must be enrolled in a related National Institutes of Health study on bacterial infections. The study is Natural History, Genetics, Phenotype and Treatment of Mycobacterial Infections. Design: - Participants will be screened with a physical exam and medical history. They will also have heart and lung function tests, as well as tests of NO production in the nose. They will provide samples of sputum and cells from inside the nose. - Before the first study visit, participants will collect sputum samples for 24 hours. They will bring the samples to the study visit. - At the first study visit, participants will have heart and lung function tests, as well as tests of NO production in the nose. They will provide blood, urine, sputum, and nasal cell samples. They will also receive sildenafil tablets to take at home. - Participants will take sildenafil tablets three times a day. - The second study visit will be 7 days after the first one. The tests from the first visit will be repeated. Participants will receive more sildenafil tablets to take on the same schedule as before. - The third and final study visit will be 30 days after the first one. The tests from the first visit will be repeated. Participants will stop taking sildenafil at this visit. - A follow-up phone call will be made about 2 weeks after the final study visit. This call will ask questions about quality of life and any symptoms or side effects of the study.

NCT ID: NCT01852942 Completed - HIV Infections Clinical Trials

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This study was designed to test the hypothesis that treatment of HIV infected subjects with losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will: 1. reverse existing lymphoid tissue fibrosis, 2. restore lymphoid tissue architecture, 3. increase the number and improve the function of peripheral and lymphatic CD4 T cells, 4. decrease levels of systemic immune activation (IA), 5. decrease size of the HIV reservoir, and 6. be safe and well tolerated.

NCT ID: NCT01849653 Completed - Clinical trials for Gonococcal Infection

Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing

SOVS-CTG
Start date: August 2014
Phase: N/A
Study type: Observational

To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.

NCT ID: NCT01846832 Completed - Infection Clinical Trials

A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

NCT ID: NCT01845246 Completed - Clinical trials for 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

Start date: January 2012
Phase: N/A
Study type: Interventional

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. The impact will be evaluated in terms of clinical and microbiological outcome, and toxicity. Secondary objectives: 1. To determine the percentage of patients reaching plasma levels considered adequate (Cmax / MIC 8-10) for the treatment of infections due to gram-negative bacilli susceptible to colistin, in the cohort of patients treated with standard doses of this drug without adjusting the dose. 2. To analyze the possible emergence of bacterial resistance to this drug and its relationship to the calculated colistin pharmacokinetic and pharmacodynamic indexes. Methods: Design: open controlled trial, blinded for the analyst, to be performed at thre tertiary care Hospitals in Barcelona. Subjects: Patients attended consecutively between 2012 and 2013 infected with multi-drug resistant gram negative bacilli and treated with colistin. Sample size: 142 cases. Intervention: Once detected the infection requiring treatment with colistin, patients will be randomized to receive the intervention or not, with a 1:1 ratio. The intervention will be performed by an Infectious Diseases physician and will consist in a recommendation on the dose of colistin based on its plasma levels 48 hours after treatment onset. Variables: peak and through colistin levels 48 hours after treatment onset, clinical, analytical and microbiological data at baseline and during follow-up of the patients. Outcome measures: clinical, microbiological and toxicity data. Analysis: Comparison of patient characteristics and outcome variables between patients who had received the intervention and those who had not. The analysis will be done by intention to treat, by biological effectiveness and by compliance with the protocol.

NCT ID: NCT01844856 Completed - Clinical trials for Complicated Intra-abdominal Infections

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

IGNITE1
Start date: August 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

NCT ID: NCT01843842 Completed - Clinical trials for Acute Upper Respiratory Tract Infections

Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; - to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.

NCT ID: NCT01843166 Completed - Quality of Life Clinical Trials

Vaginal Estrogen With Pessary Treatment

Start date: July 2012
Phase: N/A
Study type: Interventional

Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.

NCT ID: NCT01842100 Completed - Clinical trials for Sexually Transmitted Infections

To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy

Start date: September 1999
Phase: N/A
Study type: Interventional

Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by sexually transmitted infections when compared to the universal antibiotic prophylaxis strategy.

NCT ID: NCT01838213 Completed - Clinical trials for Urinary Tract Infection

Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients

ESCAPE
Start date: February 2009
Phase: N/A
Study type: Observational

This project aims at investigating the duration of human fecal carriage of bacteria harboring plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk factors for infections with such bacteria and persistence, mobility and spread of ESBL in the environment and within households. It also aims to compare different methods of detecting ESBL carriage and treat patients with urinary tract infection caused by these bacteria.