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NCT ID: NCT02922816 Terminated - Clinical trials for Infection Due to Resistant Organism

FMT for MDRO Colonization After Infection in Renal Transplant Recipients

PREMIX
Start date: December 1, 2016
Phase: Phase 1
Study type: Interventional

Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics. This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.

NCT ID: NCT02916732 Completed - Clinical trials for Incidence of ZIKV Infection on Fetus During the Pregnancy

Zika Virus Infection's Pregnancy Consequences in French Department of America

ZIKA-DFA-FE
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.

NCT ID: NCT02910557 Recruiting - Melanoma Clinical Trials

Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

Start date: August 10, 2017
Phase:
Study type: Observational

A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.

NCT ID: NCT02901717 Recruiting - Clinical trials for Catheter-related Infections

Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI

Start date: February 13, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI). Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms: - MLT Arm: Mino-Lok therapy; or - Control Arm: Antibiotic lock (±heparin). The antibiotic lock (ALT) should be comprised of the best available therapy at the sites based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines.

NCT ID: NCT02900820 Completed - Clinical trials for Respiratory Tract Infections

Safety of Discontinuing Patient Antibiotic Treatment

STOP-AB
Start date: January 2017
Phase: N/A
Study type: Interventional

There is no evidence that discontinuing antibiotic therapy for non-bacterial infections is safe. The main objective of this study is to determine whether discontinuation of antibiotic therapy when a clinician no longer considers it necessary makes any difference in terms of the number of days with severe symptoms. This is a multicentre, open-label, randomised controlled clinical trial. The study will be conducted in ten primary care centres in Spain. We will include patients from 18 to 75 years of age with uncomplicated acute respiratory tract infections (RTIs) in whom: antibiotics are not necessary; or those diagnosed with clinical conditions for which antibiotics might be necessary but according to the history and clinical examination the physician considers that antibiotics are not needed or the patient feels that the antibiotic regimen has not worked as expected; or several doses of an antibiotic have been taken from leftovers found in the household or obtained at the pharmacy without any medical prescription for a clinical condition for which antibiotics are not necessary. The patients will be randomly assigned to the usual strategy of continuing antibiotic treatment (usual intervention group) or discontinuing antibiotic therapy (novel intervention group). A sample size of 215 patients per group was calculated on the basis of a reduction of one day in the duration of severe symptoms as a clinically relevant outcome. The primary outcome will be duration of severe symptoms, i.e. symptoms scored 5 or 6 by means of a symptom diary. Secondary outcomes will include: antibiotics taken, adverse events, patient satisfaction, and complications within the first 3 months.

NCT ID: NCT02870465 Completed - Hand Fracture Clinical Trials

Hand K-wire Infections in Operating Room Versus Ambulatory Setting

Start date: September 29, 2016
Phase:
Study type: Observational

The main objective of this non-interventional, observational study is to analyze the rate and type of infection complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. The investigators will do so by prospectively collecting data on the type of fracture, handedness, co-morbidities, duration of treatment, number and type of K-wires, duration of fixation and complication rate. Patients presenting with hand fractures to the emergency room will be recruited. Patients will be recruited in multiple centres across Canada and managed according to the institutional standard. The complication type and rate will be recorded and analyzed to determine a difference of performing the procedure in the operating room or clinical setting.

NCT ID: NCT02868541 Completed - Clinical trials for Acute Respiratory Infection

Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims.

EMIRATH
Start date: January 25, 2017
Phase:
Study type: Observational

The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management. This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.

NCT ID: NCT02868450 Completed - Whipple Infection Clinical Trials

Chronic Infection With Tropheryma Whipplei: Risk Factors Related to the Host

WHIPPLE
Start date: June 7, 2013
Phase: N/A
Study type: Interventional

In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication. The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).

NCT ID: NCT02868346 Completed - Clinical trials for Sexually Transmitted Infection

Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

Start date: March 29, 2013
Phase: N/A
Study type: Interventional

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests . Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.

NCT ID: NCT02863874 Completed - Wound Infection Clinical Trials

The PLUS Study: Comparison of VicrylPlus® Versus Vicryl® for Repair of Perineal Tears

Start date: January 2016
Phase: N/A
Study type: Interventional

INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some form of perineal tear and of these 60-70% will require suturing. It is of great importance that operators are familiar with the best suturing technique and suture material in order to minimize possible associated short- and long-term sequelae. There is evidence for suturing continuously to reduce postoperative pain and superficial dyspareunia, but the choice of suture-material is still debated. The function of a suture is to close the wound to minimize the bleeding, the risk for infection and to adapt the wound edges to promote anatomic correct healing. Infection results in softened wound edges, shirked sutures, pain and dehiscence. Delayed and/or compromised wound healing is correlated with impaired strength in the affected tissue. Reported frequency of infection after first and second degree tear is between 1 and 11% where the discrepancy most likely is due to poor registration and follow-up. In 2004 Polyglactin 910 was launched with a new antibacterial coating of Triclosan (VicrylPlus®). Studies suggest a correlation between the use of VicrylPlus® and a reduction of up to 30% of surgical site infections (SSI) compared to conventional sutures in a non-colonized wound. OBJEKTIVE: The primary objective is to compare infection rates and pain intensity when using Vicryl® versus VicrylPlus® for perineal repair after delivery. Secondly, to show if there is a difference in sequelae (pelvic floor dysfunction) after one year between the two groups. METHODS The participants are randomly allocated to continuously suturing with either Vicryl® or VicrylPlus®. Sealed identical-looking envelopes are prepared and placed in the delivery room (randomized into blocks of 50) containing randomization number, sutures, declaration of informed consent and questionnaires. The participants are instructed to fill in the first questionnaire after 7 days and the second questionnaire after 8 weeks post partum. After 8 weeks all participants are offered a routine visit to the "out-patient clinic". After one year an internet-based survey will be sent out to the participants. In case of complains/signs of deficient healing after one year, the woman will be offered a clinical control. Data will be analyzed according to intention to treat and per-protocol".