Antibiotic Side Effect Clinical Trial
Official title:
Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.
There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of individualized treatment duration in early-onset infection. The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Recruiting |
NCT05499481 -
Short Against Long Antibiotic Therapy for Infected Orthopedic Sites
|
Phase 3 | |
| Recruiting |
NCT05950984 -
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
|
||
| Completed |
NCT03199911 -
Topical Antibiotic Prophylaxis for Eyelids
|
Phase 4 | |
| Completed |
NCT05355571 -
The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function and/or Faecal Microbiota Composition
|
N/A | |
| Recruiting |
NCT05699174 -
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
|
Phase 3 | |
| Completed |
NCT03087890 -
Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria
|
Phase 4 | |
| Completed |
NCT01254097 -
Probiotics in Primary Care
|
N/A | |
| Recruiting |
NCT06018792 -
Molecular Culture for the Diagnosis of Pediatric Sepsis
|
||
| Completed |
NCT06030713 -
Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome
|
N/A | |
| Active, not recruiting |
NCT05027893 -
Complications After Lower Third Molar Surgery
|
N/A | |
| Not yet recruiting |
NCT03935828 -
Effect of Topical Sinonasal Antibiotics
|
Phase 2 | |
| Not yet recruiting |
NCT06383637 -
Antibiotic Use and Resistance KAP Among Dental Interns
|
||
| Enrolling by invitation |
NCT04707092 -
Use of Preoperative and Postoperative Antimicrobial Treatment
|
Phase 4 | |
| Recruiting |
NCT03932708 -
Improving Antibiotic Use in Urgent Care Facilities
|
N/A | |
| Recruiting |
NCT04731025 -
Local Antibiotics for Breast Implants
|
Phase 3 | |
| Completed |
NCT04403334 -
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
|
Phase 4 | |
| Completed |
NCT04127682 -
Antibiotic Prescription for Children With Acute Upper Respiratory Tract Infections in Assiut District
|
||
| Completed |
NCT05742295 -
Prevention of Cefoperazone-induced Coagulopathy
|
Phase 4 | |
| Not yet recruiting |
NCT06250413 -
Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics
|
N/A |