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Communicable Diseases clinical trials

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NCT ID: NCT03840811 Completed - Clinical trials for Gonococcal Infection

Experimental Human Infection With Neisseria Gonorrhoeae

Start date: April 23, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, interventional, non-randomized, experimental infection model study with healthy adult males adults (N=32) between the ages of 18-36 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra. The duration for all participants will be about 3 weeks. Study duration will be approximately about 18 months for implementation and enrollment. The primary objectives of the present study are to: (1) compare infectivity of different isogenic mutants with wild-type (WT) N. gonorrhoeae in noncompetitive infections and to (2) assess relative fitness of the mutant in competitive infections initiated by inocula containing equivalent numbers of both WT and mutant strains for mutants with WT infectivity.

NCT ID: NCT03840148 Completed - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

CERTAIN-1
Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

NCT ID: NCT03837015 Completed - HIV-1-infection Clinical Trials

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.

NCT ID: NCT03830333 Completed - Clinical trials for Complicated Intra-abdominal Infections

Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

7625ACNPhase3
Start date: March 20, 2019
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection (cIAI). The primary hypothesis is ceftolozane/tazobactam plus metronidazole is non-inferior to meropenem, as measured by the clinical response rate at the Test-of Cure (TOC) visit in the Clinically Evaluable (CE) population.

NCT ID: NCT03824067 Completed - HIV/AIDS Clinical Trials

Impact of Point-of-Care EID for HIV-Exposed Infants

POC-EID
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

NCT ID: NCT03819712 Completed - Clinical trials for Urinary Tract Infections

Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

Predict-UTI
Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Urinary tract infections affect more than 130 million people worldwide each year. Almost 50% of women will have at least one urinary tract infection during their lifetime, usually cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment for cystitis, but their effectiveness is decreasing due to the rapid spread of multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more specifically innate immunity cells, play a key role in controlling urinary tract infections. In addition, clinical studies have shown that there is a high inter-individual variability in the ability of innate immune cells to respond to different stimuli. We therefore hypothesized that there was an association between the risk of recurrent cystitis and a deficiency of certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α, in response to one or more bacterial stimuli, particularly flagellin.

NCT ID: NCT03817645 Completed - Clinical trials for Irritable Bowel Syndrome

Panaceo "MED" for IBS (Irritable Bowel Syndrome)

PCeo-17
Start date: March 9, 2018
Phase: N/A
Study type: Interventional

Zeolite clinoptilolite is a volcanic mineral from the group of zeolites. The porous structure is associated with a large inner surface. Due to the anionic framework charge, ions (e.g., Pb^2+) can be absorbed or exchanged. The specific Panaceo PMA zeolite is approved as a class IIa medical device for the repair of the intestine inner lining. It is CE certified and complies with the relevant European Union regulations in terms of safety and effectiveness. Zeolite is known for its absorbing properties. Because of these properties and the results of several human studies, it warrants the investigation of possible effects on specific indications in human medicine, e.g. irritable bowel syndrome. The diagnosis "irritable bowel syndrome (IBS)" is according to the ROME Foundation, an US medical society. IBS is a disorder with dysfunction of the bowels, a latent inflammation is discussed. The present study aims to evaluate the following effects in patients with IBS: - Primary endpoint: effect on the symptoms of IBS. - Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as measured by the change in zonulin concentration in the stool. - Further endpoints: - Inflammation parameters and anti-inflammatory laboratory parameters. - Biodiversity of the gastrointestinal microbiome. - histamine-associated parameters. - Constipation as a possible side effect. For this purpose, a double-blind randomized controlled trial (RCT) is realized prospectively in a monocentric outpatient-controlled study. The subjects take the test compound daily (verum, reference substance) for 12 weeks and document the intake of the study-substance, intake of medications, stool-frequency and consistency. They receive "before" and "after" the intervention phase a blood and stool analysis for the determination of parameters for intestinal wall integrity (zonulin) inflammation (hsCRP, interleukin-10, calprotectin), histamine metabolism, microbiome diversity. The pilot study is realized ahead of the detailed planning of a later main study.

NCT ID: NCT03816956 Completed - Clinical trials for Infection, Bacterial

Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301

AR-301-002
Start date: May 3, 2019
Phase: Phase 3
Study type: Interventional

AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.

NCT ID: NCT03816293 Completed - Obesity Clinical Trials

SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

SUpPressSSI
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.

NCT ID: NCT03812900 Completed - Clinical trials for Respiratory Tract Infections

Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections

Start date: November 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.