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NCT Number: NCT07058415

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Antibes, Antibes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool sample 1

Other

Stool sampling at D0 for having baseline reference

Stool sample 2

Other

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

Stool sample 3

Other

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

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

    Time frame: At Day 5 after starting treatment

    using targeted metagenomics (16S rDNA)

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

    Time frame: Up to 4 months

    Simpson index,

  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.

    Time frame: Up to 4 months

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

  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.

    Time frame: Up to 4 months

    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.

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

    Time frame: Up to 4 months

    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.

  5. Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.

    Time frame: Up to 4 months

    Shannon index

  6. Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.

    Time frame: Up to 4 months

    Piélou equitability index

Study contacts

Contact information is provided by the study sponsor or research team.

Irit TOUITOU

CONTACT

[email protected]

Johan COURJON

CONTACT

[email protected]

0492035877

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.