Antibiotic Resistant Infection Clinical Trial
Official title:
The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.
Primary research question: Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic? Secondary research question: Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?
This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail. Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic. Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques. Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic. Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID. Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic. This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03309358 -
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
|
Phase 1 | |
| Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
| Completed |
NCT04212403 -
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
|
N/A | |
| Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
| Withdrawn |
NCT04462133 -
Optimal Tailored Treatment for H. Pylori Infection
|
N/A | |
| Completed |
NCT03535324 -
Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)
|
N/A | |
| Recruiting |
NCT05950984 -
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
|
||
| Withdrawn |
NCT04230746 -
Effect of Antibiotics on Urinary Microbiome
|
Early Phase 1 | |
| Active, not recruiting |
NCT03865706 -
Inulin for Infections in the Intensive Care Unit
|
Phase 2 | |
| Not yet recruiting |
NCT06028217 -
Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment
|
||
| Recruiting |
NCT05224401 -
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
|
Phase 3 | |
| Not yet recruiting |
NCT03855709 -
Antibiotic-resistant Bacterial Infection of Hepatic Patients
|
||
| Terminated |
NCT03535272 -
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
|
Phase 3 | |
| Recruiting |
NCT05902299 -
Evaluation of the Impact of the Modification of Antibiotic Susceptibility Testing on Antibiotic Prescriptions
|
||
| Recruiting |
NCT05293483 -
The Impact of Covid-19 Hospital Care on the Prevalence of MDRO in Indonesia
|
||
| Recruiting |
NCT05561504 -
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
|
||
| Recruiting |
NCT03606031 -
Digestive Microbiota Transplant
|
||
| Completed |
NCT01573195 -
Merck IISP Stewardship Grant for Antibiotic Best Practices
|
Phase 4 | |
| Not yet recruiting |
NCT03857295 -
Infections Following NeuroSurgery (INS)
|
||
| Not yet recruiting |
NCT03180983 -
Antibiotic Use in French Nursing Home
|
N/A |