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3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children

Study acronym: PYELOCOURT
StatusRecruiting
PhasePhase 4
Started2023-03-22
View on ClinicalTrials.gov ↗

Amendment history

2026-01-05
Suspended→Recruiting Study Status, Oversight, Outcome Measures, Contacts/Locations v7
Trial statusSuspended→Recruiting
Reason stoppedJoint decision by sponsor and investigator→not stated
Primary completion date2027-01→2028-01
Completion date2027-01→2028-01
Study sites14→15
2025-09-18
Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2025-09→2027-01
Completion date2025-10→2027-01
Enrollment target558→480
Study sites18→14
InterventionsFecal/Rectal Swab (Procedure), IV Antibacterial Agents (Drug), Orally antibacterial agents (Drug), PCT assay (Procedure), Renal…→Fecal/Rectal Swab (Procedure), IV Antibacterial Agents (Drug), Orally antibacterial agents (Drug), PCT assay (Procedure)
Eligibility criteria+460 characters
[...] gnosis AND positive urinalysis (white cell counts ≥ 10^4/mL) with a positive urine culture with one Gram- negative bacillus ≥ 104 UFC/mL. The child temperature will have to be measured with a thermometer according to the French national recommendations [Health Insurance website (AMELI ;see: - https://www.ameli. fr/assure/sante/bons-gestes/soins/prendre-temperature); HAS (see: https://www.has-sante. fr/jcms/c_2674284/fr/prise-en-charge [...] Initial treatment by either ceftriaxone AND/OR amikacin Outp [...] terium (cf section 6.2 of the protocol) Catheter-associated APacute pyelonephritis Known congenital an [...] [...]
Secondary endpointsdetails revised at 4 of 4 entries
Primary endpoints1 entry, revised
OccurrenceRecurrence of renalfebrile scarringurinary tract infection
Study description+444 characters
[...] have been validated for the treatment of uncomplicated AP. SinceRecently the publication ofpublished studies demonstrating(Zaoutis the non-inferiority of oral vs IV treatment2023, noMontini controlled trial has been published to shorten the duration of antibiotic treatment for AP in children, whether oral or IV. There are currently 2 ongoing non-inferiority controlled clinical trials (http://clinicaltrials.gov2024) comparinghave compared a 5-day oral treatment vs a 10-day oral treatment for urinary tract infectionAP in children. However, betweenthe 2first months and 5 yearsstudy (NCT04400110Z [...] [...]
2024-06-28
Study Status v5
Re-verified, no change to tracked fields
2024-02-07
Recruiting→Suspended Study Status, Contacts/Locations v4
Trial statusRecruiting→Suspended
Reason stoppednot stated→Joint decision by sponsor and investigator
Study sites20→18
2023-10-11
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04→confirmed 2023-03-22
Study sites19→20
Eligibility criteria+148 characters
[...] gnosis AND positive urinalysis (white cell counts ≥ 10^4/mL) AND Gram-negative rods in Gram-stained urine Initial treatment by either ceftriaxone AND/OR amikacin Out [...] Urine collected by bag Urine culture growing more than one bacteriadominant bacterium (cf section 6.2 of the protocol) Catheter-associated AP Known congenital anomalies of the ki [...] male children) Abnormal renal function for age and weight (<defined by a serum creatinine >40µmol/L before 1 year, <and >75µmol between 1 year et 3 years) Known immunocompromising c [...] discontinuation) Positive urine culture with Gram negative bacteriabacill [...] [...]
Secondary endpointsdetails revised at 3 of 4 entries
Show 2 earlier versions
2023-04-05
Study Status v2
Primary completion date2025-07→2025-09
Completion date2025-08→2025-10
Start date2023-01→2023-04
2022-12-07
Study Status, Study Description v1
Primary completion date2025-05→2025-07
Completion date2025-06→2025-08
Start date2022-11→2023-01
Study description+30 characters
[...] enal scarring can be associated with chronic renal disease. WeThe investigators hypothesize that 3 days of IV treatment is equivalent to ex [...] s with an oral therapy to prevent long-term renal scarring. WeThe investigators also hypothesize that while achieving equivalent clinical a [...]
2022-09-14
Original filing
Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 days) followed by the oral route, have a duration of 7 to 14 days (10 days in France). In children with no prior urological malformation, the global clinical and microbiological cure rate after antibiotic treatment completion is around 95%. Recurrence occurs in less than 5% of cases in the 3 months following AP. Renal scarring, when documented, concerns 15% of children 6 months after treatment. Renal scarring can be associated with chronic renal disease. The investigators hypothesize that 3 days of IV treatment is equivalent to extending to 10 days with an oral to treat AP in children. The investigators also hypothesize that while achieving equivalent clinical and prevention of re-infections in the following 3 months, 3 days of IV treatment reduces the risk of acquisition of resistant strains of Enterobacteriaceae and increases the gut microbotia diversity compared to extending to 10 days with an oral therapy.
Trial Details
NCT Number NCT05544565
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Pyelonephritis Acute
Enrollment 480 participants
Start Date 2023-03-22
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-07