Antibiotics Use and Carriage of Methicillin-resistant Staphylococci in Community Patients

NCT01489878 | Completed

• 2 other identifiers: P0811182009-AO1344-53
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, observational, multicentric open study, the investigators will compare the acquisition rates of methicillin-resistant staphylococci (coagulase-negative staphylococci and Staphylococcus aureus) nasal carriage in community patients receiving an ambulatory antibiotic treatment by either a β-lactam (amoxicillin-clavulanate or penicillins M), a macrolide, a synergistin or a fluoroquinolone.

Conditions

Methicillin Resistant Staphylococcus Aureus

Keywords

Coagulase-negative staphylococci; Staphylococcus epidermidis; Staphylococcus aureus; Anti-bacterial agents; Drug resistance, Microbial; Methicillin resistance; Β-lactams; Fluoroquinolones; Macrolides; Synergistin; General practitioners; Antibiotic selection pressure; Ambulatory antibiotherapy; Community patients

Outcome Measures

Primary Outcomes (1)

• Short-term impact of ambulatory use of β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistin or fluoroquinolones on MR-CoNS nasal carriage in community patients

  assessment of MR-CoNS carriage by nasal swabbing immediately before antibiotic use and within the 3 days following the scheduled end of antibiotherapy - comparison of acquisition rates between the 4 groups (β-lactams, macrolides, synergistin or fluoroquinolones)

  Between 5 days and 15 days

Secondary Outcomes (4)

• Mid-term impact of ambulatory use of β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistin or fluoroquinolones on MR-CoNS nasal carriage in community patients

  23 to 45 days after the scheduled end of antibiotherapy (prescribed duration)

• Short-term and mid-term impacts of ambulatory use of β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistin or fluoroquinolones on SA and MR-CoNS nasal co-carriage in community patients

  within 3 days and 23 to 45 days after the scheduled end of antibiotherapy (prescribed duration)

• Comparison of selection pressure of ambulatory use of β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistin or fluoroquinolones in terms of non-β-lactams resistances in MR-CoNS isolates colonizing community patients

  within 3 days and 23 to 45 days after the scheduled end of antibiotherapy (prescribed duration

• Short-term and mid-term impacts of ambulatory use of β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistin or fluoroquinolones on the biodiversity (species, SCCmec elements) of MR-CoNS isolates colonizing community patients

  within 3 days and 23 to 45 days after the scheduled end of antibiotherapy (prescribed duration)

Study Arms (4)

β-lactams

amoxicillin-clavulanate or penicillins M

macrolides

fluoroquinolones

synergistins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community patients receiving antibiotics prescribed by their general practitioner (GP). Patients older than 18, treated by β-lactams (amoxicillin-clavulanate or penicillins M), macrolides, synergistins or fluoroquinolones for a minimal expected duration of 5 days (whatever the indication) Hospitalization within the previous 6 months, antibiotherapy within the previous 2 months, and second line antbiotherapy after inclusion will constitute exclusion criterions.

You may qualify if:

• Age older than 18
• Prescription by a General Practitioner (investigator) of a β-lactam (amoxicillin-clavulanate or penicillins M), a macrolide, a synergistin or a fluoroquinolone for a minimal expected duration of 5 days (whatever the indication)
• Informed consent to the study protocol
• Hospitalization within the previous 6 months
• Antibiotherapy within the previous 2 months
• Combination antibiotherapy

You may not qualify if:

• Withdrawal of informed consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat-Claude Bernard teaching hospital (AP-HP) and Xavier Bichat medical school (Denis Diderot - Paris 7 university)

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Three samples of nasal flora should be obtained for each included patient: (i) the first one before antibiotic exposure (at inclusion, by the patient's GP) (ii) the second and third ones at the GP's office at the end and 23 to 45 days after the termination of antibiotherapy, respectively.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Raymond Ruimy, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 12, 2011
• Study Start: March 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

FR (1)