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Infections clinical trials

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NCT ID: NCT05799716 Not yet recruiting - Bacteremia Clinical Trials

Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are: 1. How effective IVIG is in preventing donor-derived infections 2. Does IVIG has potential immunomodulatory effect on transplanted organs

NCT ID: NCT05796362 Not yet recruiting - Infectious Disease Clinical Trials

A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

Start date: April 2023
Phase: Phase 1
Study type: Interventional

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

NCT ID: NCT05789550 Not yet recruiting - H Pylori Infection Clinical Trials

HELICOBACTER PYLORI INFECTION IN TYPE 2 DIABETES MELLITUS IN ASSIUT UNIVERSITY HOSPITAL

Start date: April 1, 2023
Phase:
Study type: Observational

The aim is to study the association of H. pylori infection with T2DM and its relation with glycated hemoglobin (HbA1c) levels

NCT ID: NCT05775276 Not yet recruiting - Clinical trials for Incidence of Mesh Infection In Hernioplasty

Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures

Start date: March 2023
Phase: N/A
Study type: Interventional

The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit University.

NCT ID: NCT05771519 Not yet recruiting - HIV Infections Clinical Trials

Developing an HIV Disclosure Intervention for Men in Uganda

DASH
Start date: May 2025
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care. Participants assigned to the intervention group will likely participate in the following: - Sexual health education - Cognitive behavioral therapy strategies - Problem-solving skills building - Motivational interviewing - Developing a personalized HIV disclosure plan - Communication skills building - Role-playing disclosure strategies

NCT ID: NCT05770622 Not yet recruiting - Sepsis Clinical Trials

Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)

VANCAPP
Start date: August 2024
Phase: Phase 4
Study type: Interventional

A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.

NCT ID: NCT05766124 Not yet recruiting - Pleural Infection Clinical Trials

Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)

Start date: June 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Objectives: A pilot study to compare the therapeutic and safety profiles between low(2.5mg) and standard(10mg) doses of intrapleural tissue plasminogen activator(tPA) in uncontrolled pleural infection. The study design will be tested for its trialability. Hypothesis: 2.5mg tPA has comparable therapeutic efficacy and less bleeding complications to 10mg tPA. Design and subjects: A pilot, single-centre, two-arm, double-blinded, randomized controlled trial(RCT) which includes subjects with uncontrolled pleural infection, with follow-up till 90 days after hospital discharge. Interventions: Recruited subjects will be randomized in 1:1 ratio to receive a maximum of 6 doses of intrapleural tPA starting at either 2.5mg or 10mg. A clinical decision is allowed at the third dose to continue with the assigned dose or escalate to 10mg to complete the course based on the clinical response, without breaking the blinding. Main outcome measures: The primary outcome is survival at 90 days and without the need for surgical intervention. Secondary outcomes include the need for additional pleural interventions, number of decisions to choose 10mg intrapleural tPA at the third dose, clinical and radiographic response after the treatment course, safety profiles especially bleeding complications, and the number and reason for protocol violation. Data analysis and expected results: Data will be analyzed on an intention-to-treat basis for all randomized subjects. The clinical outcomes will be compared with a regression model built to adjust for confounding covariates. The data on therapeutic efficacy and bleeding complications will inform the power calculation of sample size in subsequent full-scale multicentred RCT incorporating the current study design.

NCT ID: NCT05763693 Not yet recruiting - Infectious Disease Clinical Trials

Vitality in Infants Via Azithromycin for Neonates Trial

VIVANT
Start date: July 31, 2024
Phase: Phase 4
Study type: Interventional

Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.

NCT ID: NCT05761197 Not yet recruiting - Clinical trials for Early Childhood Caries

Oropharyngeal Candidiasis (OPC) and S-ECC

Oral-Thrush
Start date: July 1, 2024
Phase:
Study type: Observational

The overall objective of this study is to investigate the association of early Candida infection (known as oral thrush or oropharyngeal candidiasis, OPC) in children during the first year of life with the onset and severity of severe early childhood caries (S-ECC).

NCT ID: NCT05750576 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate

DRESSING-ECMO
Start date: February 2023
Phase: N/A
Study type: Interventional

The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection