Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT03825874 (MIKA) for Urinary Tract Infections, Urinary Tract Infections in Children is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children (MIKA) 200 Pediatric
Clinical Trial NCT03825874 (MIKA) is an observational study for Urinary Tract Infections, Urinary Tract Infections in Children that is recruiting. It started on 19 January 2019 with plans to enroll 200 participants. Led by Centre Hospitalier Intercommunal Creteil, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 27 August 2025.
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 o...Show More
Official Title
Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection
Conditions
Urinary Tract InfectionsUrinary Tract Infections in ChildrenOther Study IDs
- MIKA
- 2017-A02372-51 (Other Identifier) (ID-RCB)
NCT ID Number
Start Date (Actual)
2019-01-19
Last Update Posted
2025-08-27
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
200
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
amikacin IV Febrile urinary tract infection treated with amikacin IV | 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 | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Presence of E-BLSE in stools | ano-rectal swab | day 4 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Type of E-BLSE strain in stools | day 4 | |
Rate of enzymatic resistance of E-BLSE strain in stools | 4 days | |
Fever | Time of apyrexia | 4 days |
side effects due to antibiotic therapy | at 1.5 months | |
rate of relapse of urinary tract infection | 1.5 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Months
Eligible Sexes
All
- 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)
- 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
Centre Hospitalier Intercommunal CreteilStudy Central Contact
Contact: Fouad Madhi, MD, +33157025422, [email protected]
20 Study Locations in 1 Countries
Cabinet du Dr Benali, Charenton-le-Pont, 94220, France
Hadj Benali, Contact
Recruiting
Cabinet du Dr Coicadan, Chennevières-sur-Marne, 94430, France
Lucette Coicadan, Contact
Recruiting
Cabinet du Dr Corrard, Combs-la-Ville, 77380, France
François Corrard, Contact
Recruiting
Cabinet du Dr Thollot, Essey-lès-Nancy, 54270, France
Franck Thollot, Contact
Recruiting
CHU Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
Irina Craiu, Contact, [email protected]
Not yet recruiting
157 Avenue du Général Leclerc, Maisons-Alfort, 94700, France
Annie ELBEZ, Contact
Not yet recruiting
Centre Hospitalier de Meaux, Meaux, France
Olivier Vignaud, Contact, [email protected]
Not yet recruiting
Cabinet du Dr Deberdt, Nogent-sur-Marne, 94130, France
Patrice Deberdt, Contact
Recruiting
Cabinet du Dr Wollner, Nogent-sur-Marne, 94130, France
Alain Wollner, Contact
Recruiting
Cabinet du Dr Romain, Paris, 75015, France
Olivier Romain, Contact
Recruiting
Cabinet du Dr Turberg-Romain, Paris, 75015, France
Catherine Turberg-Romain, Contact
Recruiting
Cabinet du Dr Michot, Paris, 75016, France
Anne-Sylvestre Michot, Contact
Recruiting
Hospital Robert-Debré, Paris, France
Alexis Rybak, Contact
Recruiting
Cabinet du Dr Cohen, Saint-Maur-des-Fossés, 94100, France
Robert Cohen, Contact
Mohammed Benani, Sub-Investigator
Nadia D'Ovidio, Sub-Investigator
Marc Koskas, Sub-Investigator
Aurélie SELLAM, Sub-Investigator
Recruiting
Cabinet du Dr Werner, Villeneuve-lès-Avignon, 30400, France
Andreas Werner, Contact
Recruiting
CHI Villeneuve-Saint-Georges, Villeneuve-Saint-Georges, 94195, France
Aurélie GARRAFFO, Contact
Recruiting
13 Villa Beauséjour, Vincennes, 94300, France
Christophe BATARD, Contact
Not yet recruiting
Île-de-France Region
Jean Verdier Hospital, Bondy, Île-de-France Region, France
Aurélien Galerne, Contact, [email protected]
Recruiting
Antoine Beclère Hospital, Clamart, Île-de-France Region, France
Vincent Gadjos, Contact, [email protected]
Not yet recruiting
André Mignot Hospital, Le Chesnay, Île-de-France Region, France
Marie-Aliette Dommergues, Contact, [email protected]
Not yet recruiting