Urinary Tract InfectionsMIKANCT03825874
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
An observational study of Urinary Tract Infections and Urinary Tract Infections in Children, run by Centre Hospitalier Intercommunal Creteil at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Urinary Tract Infections, Urinary Tract Infections in Children
- What is being tested?
- Amikacin and usual antibiotic treatment
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 20 sitesFrance
- Study dates
- 19 Jan 2019to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- Child
Study population: Child from 3 months to 3 years treated for febrile urinary tract infection
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Jean Verdier Hospital
Bondy, Île-de-France Region
Aurélien Galerne, aurelien.galerne@aphp.fr
- Recruiting
Cabinet du Dr Benali
Charenton-le-Pont, 94220
Hadj Benali
- Recruiting
Cabinet du Dr Coicadan
Chennevières-sur-Marne, 94430
Lucette Coicadan
- Not yet recruiting
Antoine Beclère Hospital
Clamart, Île-de-France Region
Vincent Gadjos, vincent.gajdos@abc.aphp.fr
- Recruiting
Cabinet du Dr Corrard
Combs-la-Ville, 77380
François Corrard
- Recruiting
Cabinet du Dr Thollot
Essey-lès-Nancy, 54270
Franck Thollot
- Not yet recruiting
André Mignot Hospital
Le Chesnay, Île-de-France Region
Marie-Aliette Dommergues, madommergues@ch-versailles.fr
- Not yet recruiting
CHU Le Kremlin-Bicêtre
Le Kremlin-Bicêtre
Irina Craiu, craiu@voila.fr
- Not yet recruiting
157 Avenue du Général Leclerc
Maisons-Alfort, 94700
Annie ELBEZ
- Not yet recruiting
Centre Hospitalier de Meaux
Meaux
Olivier Vignaud, o-vignaud@ch-meaux.fr
- Recruiting
Cabinet du Dr Deberdt
Nogent-sur-Marne, 94130
Patrice Deberdt
- Recruiting
Cabinet du Dr Wollner
Nogent-sur-Marne, 94130
Alain Wollner
- Recruiting
Cabinet du Dr Romain
Paris, 75015
Olivier Romain
- Recruiting
Cabinet du Dr Turberg-Romain
Paris, 75015
Catherine Turberg-Romain
- Recruiting
Cabinet du Dr Michot
Paris, 75016
Anne-Sylvestre Michot
- Recruiting
Hospital Robert-Debré
Paris
Alexis Rybak
- Recruiting
Cabinet du Dr Cohen
Saint-Maur-des-Fossés, 94100
Robert Cohen
Mohammed Benani
- Recruiting
Cabinet du Dr Werner
Villeneuve-lès-Avignon, 30400
Andreas Werner
- Recruiting
CHI Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, 94195
Aurélie GARRAFFO
- Not yet recruiting
13 Villa Beauséjour
Vincennes, 94300
Christophe BATARD
About this study
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
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.
- Being tested
- Amikacin, usual antibiotic treatment
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinOther
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.
usual antibiotic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| amikacin IV | Febrile urinary tract infection treated with amikacin IV Receives: Other: Amikacin | |
| Other antibiotics | Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime Receives: Other: usual antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of E-BLSE in stools
ano-rectal swab
Measured: day 4
Secondary outcomes (5)
Type of E-BLSE strain in stools
Measured: day 4
Rate of enzymatic resistance of E-BLSE strain in stools
Measured: 4 days
Fever
Time of apyrexia
Measured: 4 days
side effects due to antibiotic therapy
Measured: at 1.5 months
rate of relapse of urinary tract infection
Measured: 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start19 Jan 2019
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fouad MADHI, MD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825874
- Sponsor's protocol ID
- MIKA
- Other IDs
- 2017-A02372-51
- Acronym
- MIKA
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2018
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03825874
- Acronym / sponsor ID
- MIKA / MIKA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amikacin IV | – | Other: AmikacinFebrile urinary tract infection treated with amikacin IV |
| Other antibiotics | – | Other: usual antibiotic treatmentFebrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Child from 3 months to 3 years treated for febrile urinary tract infection
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmikacinA 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 | amikacin IV |
| usual antibiotic treatmentA 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 | Other antibiotics |
Primary outcome
Presence of E-BLSE in stools
Time frame: day 4
ano-rectal swab
5 secondary outcomes
Type of E-BLSE strain in stools
Time frame: day 4
Rate of enzymatic resistance of E-BLSE strain in stools
Time frame: 4 days
Fever
Time frame: 4 days
side effects due to antibiotic therapy
Time frame: at 1.5 months
rate of relapse of urinary tract infection
Time frame: 1.5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fouad MADHI, MD principal investigator
CHI Créteil
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Urinary Tract Infections in Children, run by Centre Hospitalier Intercommunal Creteil at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fouad Madhi, MD (+33157025422, fouad.madhi@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of E-BLSE in stools (time frame: day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.