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Communicable Diseases clinical trials

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NCT ID: NCT04287478 Terminated - Clinical trials for Urinary Tract Infection Bacterial

Bacteriophage Therapy in Patients With Urinary Tract Infections

Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

NCT ID: NCT04250168 Terminated - Ebola Virus Disease Clinical Trials

Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

Bact_EVD
Start date: November 11, 2019
Phase:
Study type: Observational

Despite access to experimental Ebola Virus Disease (EVD)-specific treatments, about 30% of patients still die in the Ebola Treatment Centers (ETC) in DRC. There is limited study done about the potential contribution of bacterial co-infections (in particular bloodstream infections) to this adverse outcome, as blood cultures were so far rarely available in epidemic areas. Findings from patients treated in Europe and the USA, and case discussions in the field call for further investigation. Building further on an ongoing microbiological surveillance project of ITM and INRB in DRC, we are able to set up a research project which will pilot in a standardized manner clinical bacteriology tools (bacterial blood cultures, biomarkers as CRP, procalcitonin and white blood cell differential count, and clinical early warning scores) to study bacterial bloodstream infection in EVD patients in the N-Kivu/Ituri outbreak. This project will add evidence on 1) frequency, causative pathogen and antibiotic resistance profiles of bacterial bloodstream infections, as well as 2) the predictive value of biomarkers and early warning scores, in EVD patients at different timepoints during hospitalization in an ETC in DRC. The results will inform appropriate antibiotic treatment in an EVD setting and improve patient outcomes.

NCT ID: NCT04240886 Terminated - Clinical trials for Invasive Fungal Infections

Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds

AEGIS
Start date: January 4, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).

NCT ID: NCT04225897 Terminated - Clinical trials for Respiratory Syncytial Virus (RSV)

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

REVIRAL 1
Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI

NCT ID: NCT04163679 Terminated - Infection Clinical Trials

Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Start date: September 18, 2019
Phase: N/A
Study type: Interventional

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NCT ID: NCT04081480 Terminated - Clinical trials for Varicella Zoster Virus Infection

Pharmacokinetics of Valacyclovir Oral Solution in Children

VALID2
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing. The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir. Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.

NCT ID: NCT04042077 Terminated - Clinical trials for Surgical Site Infection

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

DRESS
Start date: September 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.

NCT ID: NCT04025983 Terminated - Clinical trials for Helicobacter Pylori Infection

Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection

GasHp
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.

NCT ID: NCT04000555 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)

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

The purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.

NCT ID: NCT03973697 Terminated - Clinical trials for Recurrent Clostridium Difficile Infection

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).