Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria (HOPE)

Centre Hospitalier Universitaire de Nice

Status

Not yet enrolling

Conditions

Osteoarticular Material Infection

Treatments

Other: Stool sample 3

Other: Stool sample 2

Other: Stool sample 1

Study type

Interventional

Funder types

Other

Identifiers

NCT07058415

22-CONS-01

Details and patient eligibility

About

In the event of suspected osteoarticular material infection (OAMI), broad-spectrum probabilistic antibiotic therapy is recommended immediately after revision surgery. There are no efficacy data to suggest that any particular to favour any particular molecule. However, the choice may depend on the impact on the microbiota and on Enterobacteriaceae colonization with multi-resistant Enterobacteriaceae. Our aim is to evaluate three different strategies efepime+daptomycin C+D, piperacillin-tazobactam+daptomycin (PT+D) and ceftobiprole (CFB).

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Indication for prosthetic revision (PTG, PUC, PTH or hip hemiarthroplasty, PTE) or internal osteosynthesis with suspicion of IOAM following the opinion of a Réunion de concertation Pluridisciplinaire (RCP) on complex osteoarticular infections
Normal CPK level according to laboratory standard
Social security affiliation
Signature of informed consent
Negative pregnancy test for women of childbearing age.

Exclusion criteria

Antibiotic therapy in the 3 months prior to inclusion
Clinical or radiological signs making HAI highly probable: scar discharge and/or peri-scar cellulitis fistula or abscess, bacteremia
positive bacterial culture from joint puncture or biopsy prior to revision
Chronic inflammatory bowel disease.
Previous surgical resection of small intestine or colon.
Hypersensitivity to daptomycin or any of its excipients.
Hypersensitivity to cefepime or any of its excipients or to other beta-lactamins.
Hypersensitivity to piperacillin+tazobactam or to any of the excipients or to other beta-lactamines.
Hypersensitivity to ceftobiprole or to any of the excipients or to other beta-lactamines.
Renal insufficiency with GFR < 50ml/min/1.73 m2 (CKD-EPI).
Treatment with bosentan.
Treatment with probenecid.
Pre-existing seizure disorder.
Contraindication to L-arginine, acidosis, hyperkalemia that cannot be corrected.
Treatment with HMG-CoA reductase inhibitors.
Treatment with statins (pitavastin, pravastatin, rosuvastatin) or glyburide.
Patients in a medical emergency.
Pregnant or breast-feeding women.
Patient participating in another ongoing trial.
Mental state rendering the patient incapable of understanding this research.
Patient deprived of liberty by administrative or judicial decision.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Céfépime + Daptomycine

Active Comparator group

Description:

First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28).

Treatment:

Other: Stool sample 1

Other: Stool sample 2

Other: Stool sample 3

Pipéracilline-Tazobactam + Daptomycine

Active Comparator group

Description:

Treatment:

Other: Stool sample 1

Other: Stool sample 2

Other: Stool sample 3

Ceftobiprole