MIKA: Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Study Details
Study Description
Brief Summary
The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country.
In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO).
The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| amikacin IV Febrile urinary tract infection treated with amikacin IV |
Other: Amikacin
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
|
| Other antibiotics Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime |
Other: usual antibiotic treatment
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
|
Outcome Measures
Primary Outcome Measures
- Presence of E-BLSE in stools [day 4]
ano-rectal swab
Secondary Outcome Measures
- Type of E-BLSE strain in stools [day 4]
- Rate of enzymatic resistance of E-BLSE strain in stools [4 days]
- Fever [4 days]
Time of apyrexia
- side effects due to antibiotic therapy [at 1.5 months]
- rate of relapse of urinary tract infection [1.5 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Infant and child (age ≥ 3 months and <3 years)
-
Patient treated for febrile urinary tract infection as monotherapy with amikacin IV, ceftriaxone (IV or IM) or cefixime PO *
-
Whose parents read and understood the newsletter and whose express consent was collected
-
Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
Exclusion Criteria:
-
Child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside)
-
Antibiotherapy in progress or discontinued in the previous 7 days
-
Hospitalized child
-
Refusal of one of the parents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Antoine Beclère Hospital | Clamart | Ile-de France | France | |
| 2 | Jean Verdier Hospital | Bondy | Ile-de-France | France | |
| 3 | André Mignot Hospital | Le Chesnay | Ile-de-France | France | |
| 4 | Cabinet du Dr Benali | Charenton-le-Pont | France | 94220 | |
| 5 | Cabinet du Dr Coicadan | Chennevières-sur-Marne | France | 94430 | |
| 6 | Cabinet du Dr Corrard | Combs-la-Ville | France | 77380 | |
| 7 | Cabinet du Dr Thollot | Essey-lès-Nancy | France | 54270 | |
| 8 | CHU Le Kremlin-Bicêtre | Le Kremlin-Bicêtre | France | ||
| 9 | 157 Avenue du Général Leclerc | Maisons-Alfort | France | 94700 | |
| 10 | Centre Hospitalier de Meaux | Meaux | France | ||
| 11 | Cabinet du Dr Deberdt | Nogent-sur-Marne | France | 94130 | |
| 12 | Cabinet du Dr Wollner | Nogent-sur-Marne | France | 94130 | |
| 13 | Cabinet du Dr Romain | Paris | France | 75015 | |
| 14 | Cabinet du Dr Turberg-Romain | Paris | France | 75015 | |
| 15 | Cabinet du Dr Michot | Paris | France | 75016 | |
| 16 | Hospital Robert-Debré | Paris | France | ||
| 17 | Cabinet du Dr Cohen | Saint-Maur-des-Fossés | France | 94100 | |
| 18 | Cabinet du Dr Werner | Villeneuve-lès-Avignon | France | 30400 | |
| 19 | CHI Villeneuve-Saint-Georges | Villeneuve-Saint-Georges | France | 94195 | |
| 20 | 13 Villa Beauséjour | Vincennes | France | 94300 |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal Creteil
Investigators
- Principal Investigator: Fouad MADHI, MD, CHI Créteil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIKA
- 2017-A02372-51