Acquisition of Resistant Enterobacteria During Oral Drug Challenge for Betalactams in Children
ARET
ARET
Sponsor study identifier
Secondary identifiers
OTHER · IDRCB number
observational
50
1 country
1
Study Start
March 23, 2021
Actual (reported)Primary Completion
January 31, 2024
Actual (reported)Study Completion
January 31, 2024
Actual (reported)Direct drug provocation testing, without prior skin or in vitro testing, is the reference standard for confirming the diagnosis of drug hypersensitivity reactions in children reporting mild and delayed-onset reactions. However, optimal protocol(s) have not been standardized. Although a 2-days' provocation testing protocol is effective, increasing its duration (up to 14 days) may improve its diagnosis performance without increasing the risk of severe reactions. However, a prolonged provocation testing could increase the risk of emergence of bacterial resistances in the digestive flora. Longer duration could be associated with the emergence of extended-spectrum betalactamase producing enterobacteria. However, this point has never been confirmed. The study will include children (0-18 years); referring for histories of mild and delayed-onset reactions to betalactams. drug provocation testing will be performed with the suspected BLs in our department, as in clinical practice. Two groups of patients will be compared: a group performing short provocation testing (arbitrary defined as lasting 1 to 4 days) and a group with prolonged drug provocation testing (arbitrary defined as lasting 5-8 days). A rectal swab will be collected for each patient before the provocation testing, a second one at the end of the provocation testing. Each sample will be analyzed to detect the presence extended-spectrum betalactamase -producing enterobacteria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2019
Actual (reported)August 20, 2019
Actual (reported)March 23, 2021
Actual (reported)January 31, 2024
Actual (reported)January 31, 2024
Actual (reported)Acquisition of at least one strain of extended-spectrum betalactamase-producing enterobacteria
Bacteriological culture with gram-negative bacteria-specific agar. Bacterial colonies will be identified by mass spectrometry (Matrix Assisted Laser Desorption Ionization technique - Time of Flight, MALDI-TOF). Antibiogram.
24 months
Acquisition of at least one strain of third generation cephalosporin-resistant gram-negative bacteria
24 months
Metagenomic analysis of intestinal microbiota
24 months
Minors performing a short (1-4 days) drug provocation test
Minors performing a prolonged (5-8 days)drug provocation test
Rectal swab before and after the drug provocation testing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Minors in consultation at Necker Hospital
Hôpital Necker-Enfants Malades
Paris, Paris, 75015, France
Faeces
Guillaume Lezmi, Doctor (PHU)
Assistance Publique - Hôpitaux de Paris
50 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2019
First Posted
August 20, 2019
Study Start
March 23, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 31, 2024
Actual (reported)Study Completion
January 31, 2024
Actual (reported)Last Updated
May 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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