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Trial record 24 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children (MIKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03825874
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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
Urinary Tract Infections Urinary Tract Infections in Children Other: Amikacin Other: usual antibiotic treatment

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Group/Cohort 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.

Primary Outcome Measures :
  1. Presence of E-BLSE in stools [ Time Frame: day 4 ]
    ano-rectal swab

Secondary Outcome Measures :
  1. Type of E-BLSE strain in stools [ Time Frame: day 4 ]
  2. Rate of enzymatic resistance of E-BLSE strain in stools [ Time Frame: 4 days ]
  3. Fever [ Time Frame: 4 days ]
    Time of apyrexia

  4. side effects due to antibiotic therapy [ Time Frame: at 1.5 months ]
  5. rate of relapse of urinary tract infection [ Time Frame: 1.5 months ]

Biospecimen Retention:   Samples Without DNA
anorectal swab

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Child from 3 months to 3 years treated for febrile urinary tract infection

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03825874

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Contact: Fouad Madhi, MD +33157025422

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Antoine Beclère Hospital Not yet recruiting
Clamart, Ile-de France, France
Contact: Vincent Gadjos   
Jean Verdier Hospital Recruiting
Bondy, Ile-de-France, France
Contact: Aurélien Galerne   
André Mignot Hospital Not yet recruiting
Le Chesnay, Ile-de-France, France
Contact: Marie-Aliette Dommergues   
Cabinet du Dr Vie Le Sage Recruiting
Aix-les-Bains, France, 73100
Contact: François Vie Le Sage         
Cabinet du Dr De Pontual Recruiting
Bondy, France, 93160
Contact: Loic De Pontual         
Hopital Ambroise Paré Recruiting
Boulogne-Billancourt, France
Contact: Valerie Soussan-banini   
Cabinet du Dr Belaroussi Recruiting
Boulogne, France, 92100
Contact: Nassira Belaroussi         
Hôpital Saint Camille Recruiting
Bry-sur-Marne, France, 94360
Contact: Xiména Sanchez-Bernier         
Cabinet du Dr Derkx Recruiting
Champigny-sur-Marne, France, 94500
Contact: Veronique Derkx         
Cabinet du Dr Benali Recruiting
Charenton-le-Pont, France, 94220
Contact: Hadj Benali         
Cabinet du Dr Coicadan Recruiting
Chennevières-sur-Marne, France, 94430
Contact: Lucette Coicadan         
Cabinet du Dr Broussin Recruiting
Châtillon, France, 92320
Contact: Bénédicte Broussin         
Cabinet du Dr Corrard Recruiting
Combs-la-Ville, France, 77380
Contact: François Corrard         
Cabinet du Dr Donikian-Pujol Recruiting
Crolles, France, 38920
Contact: Isabelle Donikian-Pujol         
CHI Créteil Not yet recruiting
Créteil, France, 94000
Contact: Fouad Madhi, MD    145175422 ext 33   
Sub-Investigator: Sandra Biscardi, MD         
Cabinet du Dr Thollot Recruiting
Essey-lès-Nancy, France, 54270
Contact: Franck Thollot         
CHU Le Havre Not yet recruiting
Le Havre, France
Contact: abdelmalek belgaid   
CHU Le Kremlin-Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France
Contact: Irina Craiu   
Roger Salengro Hospital Recruiting
Lille, France
Contact: Marion Lagree   
Centre Hospitalier Général de Longjumeau Not yet recruiting
Longjumeau, France
Contact: Sarah Ducrocq   
CHU Lyon Not yet recruiting
Lyon, France
Contact: Yves Gillet   
157 Avenue du Général Leclerc Not yet recruiting
Maisons-Alfort, France, 94700
Contact: Annie ELBEZ         
Cabinet du Dr Defives Recruiting
Marquette-lez-Lille, France, 59520
Contact: Isabelle Defives         
Centre Hospitalier de Meaux Not yet recruiting
Meaux, France
Contact: Olivier Vignaud   
Cabinet du Dr Bodin Recruiting
Montgeron, France, 91230
Contact: Marie-José Bodin         
CHU Lenval Recruiting
Nice, France
Contact: Hervé Haas   
Cabinet du Dr Deberdt Recruiting
Nogent-sur-Marne, France, 94130
Contact: Patrice Deberdt         
Cabinet du Dr Wollner Recruiting
Nogent-sur-Marne, France, 94130
Contact: Alain Wollner         
Centre Hospitalier d'Orsay Not yet recruiting
Orsay, France
Contact: Marion Decobert   
Cabinet du Dr D'acremont Recruiting
Paris, France, 75009
Contact: Gwenaelle D'acremont         
Cabinet du Dr Romain Recruiting
Paris, France, 75015
Contact: Olivier Romain         
Cabinet du Dr Turberg-Romain Recruiting
Paris, France, 75015
Contact: Catherine Turberg-Romain         
Cabinet du Dr Michot Recruiting
Paris, France, 75016
Contact: Anne-Sylvestre Michot         
CHU Robert-Debré Recruiting
Paris, France, 75019
Contact: Stéphane Bonacorsi         
Sub-Investigator: Marion Caseris         
Hospital Trousseau Not yet recruiting
Paris, France
Contact: Emmanuel Grimpel   
CHU Rouen Recruiting
Rouen, France
Contact: Didier Pinquier   
Cabinet du Dr Cohen Recruiting
Saint-Maur-des-Fossés, France, 94100
Contact: Robert Cohen         
Sub-Investigator: Mohammed Benani         
Sub-Investigator: Nadia D'Ovidio         
Sub-Investigator: Marc Koskas         
Cabinet du Dr Bakhache Recruiting
Saint-Quentin, France, 02100
Contact: Pierre Bakhache         
Cabinet du Dr Nave Recruiting
Sélestat, France, 67600
Contact: Isabelle Nave         
Cabinet du Dr Werner Recruiting
Villeneuve-lès-Avignon, France, 30400
Contact: Andreas Werner         
CHI Villeneuve-Saint-Georges Recruiting
Villeneuve-Saint-Georges, France, 94195
Contact: Emilie Georget         
13 Villa Beauséjour Not yet recruiting
Vincennes, France, 94300
Contact: Christophe BATARD         
Clinique de l'Essonne Not yet recruiting
Évry, France, 91000
Contact: Halim Bekri         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Principal Investigator: Fouad MADHI, MD CHI Créteil

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Responsible Party: Centre Hospitalier Intercommunal Creteil Identifier: NCT03825874     History of Changes
Other Study ID Numbers: MIKA
2017-A02372-51 ( Other Identifier: ID-RCB )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents