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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stool sample 1

    Other intervention

    Stool sampling at D0 for having baseline reference

  • Stool sample 2

    Other intervention

    Stool sampling at D5 to study the impact of antibiotics on microbiota

  • Stool sample 3

    Other intervention

    Stool sampling at DX+28 to study the impact of antibiotics on microbiota

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Céfépime + DaptomycineActive comparator 3 interventions
Group B: Pipéracilline-Tazobactam + DaptomycineActive comparator 3 interventions
Group C: CeftobiproleExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Compare changes in gut microbiota biodiversity between Day1 and Day5 between populations treated with C+D, PT+D and CFB in suspected Osteoarticular infection on equipment

using targeted metagenomics (16S rDNA)

Time frame
At Day 5 after starting treatment

Secondary outcomes

1

Compare the evolution between Day1/end of treatment+28 Days and between Day 5/end of treatment+28D of microbiota biodiversity of each patient population treated with different antibiotics for suspected Osteoarticular infection on equipment

Simpson index,

Time frame
Up to 4 months
2

Compare the rate of acquisition of multidrug-resistant extended-spectrum beta-lactamase-producing intestinal Enterobacteria between antibiotic strategies on samples at Day5 and DX+28 in patients with no multidrug-resistant Enterobacteria at Day1.

Stool culture on a selective medium at Day1, Day5 and Day X+28

Time frame
Up to 4 months
3

Compare the rate of acquisition of carbapenemase-producing intestinal multi-resistant Enterobacteriaceae (EPC) between antibiotic strategies on samples taken at D5 and DX+28 in patients with no multi-resistant Enterobacteria at D1.

The appearance of EPC-type multi-resistant Enterobacteriaceae will be determined by stool culture on a selective medium selective medium (mSuperCARBA, MAST diagnostic) at D1, D5 and DX+28.

Time frame
Up to 4 months
4

Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection.

Inadequacy of one of the three probabilistic strategies will be defined by a documented infection with a bacterium resistant to both antibiotics in the case of dual therapy, or to ceftobiprole in the case of monotherapy.

Time frame
Up to 4 months

Other outcomes

Sponsors and contacts

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