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

Primary Purpose

Pyelonephritis Acute

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
IV Antibacterial Agents
Orally antibacterial agents
Fecal/Rectal Swab
PCT assay
Renal scintigraphy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyelonephritis Acute focused on measuring Pyelonephritis acute, Antibiotic therapies, Renal scar, Paediatric

Eligibility Criteria

1 Month - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 1 month and < 3 years
  • For children younger than 3 months, gestational age > 34 WA
  • First episode of urinary tract infection
  • AP defined by temperature ≥ 38°C on day of diagnosis 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
  • Outpatient or hospitalised

Non-inclusion Criteria:

  • Urine collected by bag
  • Urine culture growing more than one bacteria
  • Catheter-associated AP
  • Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm)
  • Previous surgery of the genitourinary tract (except circumcision in male children)
  • Abnormal renal function for age and weight (<40µmol/L before 1 year, <75µmol between 1 year et 3 years)
  • Known immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)
  • Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)
  • Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (include cephalosporin et beta-lactams) and amikacin (include aminoside)
  • Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (include sulfonamide) and cefixime (include cephalosporin)
  • Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)
  • Known severe hepatic insufficiency
  • Known G6PD deficiency
  • No written consent from holders of parental authority
  • Non-affiliation to a social security system (as beneficiary or entitled person)
  • Children whose follow-up is not carried out in the centre
  • Participation in another interventional or minimal risk trial

Randomization criteria :

  • Three days of taking antibiotics (IV or IM) (no interruption or discontinuation)
  • Positive urine culture with Gram negative bacteria ≥ 10^4 UFC/mL
  • Favorable clinical outcome at day 3 defined by temperature < 38°C at day 3 and absence of fever measured > 38°C for at least 12 hours AND no abdominal pain AND no feeding problem
  • No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm) on the renal ultrasound performed between D0 and D3
  • No more than 1 type of bacteria
  • No bacteria resistant to the initial antibiotic treatment AND cefixime OR cotrimoxazole

Sites / Locations

  • CH Sud Francilien
  • Logjumeau hospitalRecruiting
  • Orsay hospitalRecruiting
  • Caremeau hospital
  • Antoine Beclère Hospital
  • Children hospital
  • Ambroise Paré hospitalRecruiting
  • Arnaud de villeneuve Hospital
  • Arnaud de Villeneuve hospital
  • Children-Teenager hospital
  • Jeanne Flandre Hospital
  • Meaux Hospital
  • Charles Nicole Hospital
  • Jean Verdier Hospital
  • Delafontaine Hospital
  • Intercomunal Créteil Hospital
  • Kremlin Bicêtre Hospital
  • Andre mignot hospitalRecruiting
  • Robert Debré Hospital
  • Robert Debré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group: Discontinuation of treatment

Control group: Usual practice

Arm Description

For patients randomized in the experimental group, the patient receives 3-day IV therapy and the treatment is interrupted.

For patients randomized in the control group, the treatment for acute pyelonephritis is based on the attending clinician's practice and according to the usual practice: 3-day IV therapy followed by a 7-day oral antibiotic therapy.

Outcomes

Primary Outcome Measures

Occurrence of renal scarring
Demonstrate the non-inferiority of a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy for the treatment of AP in children in term of the occurrence of renal scarring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy

Secondary Outcome Measures

Clinical cure
Demonstrate the non-inferiority of a 3-day IV antibiotic treatment versus a 3-day IV followed by 7-day oral antibiotic treatment for AP in children 1 month to 3 years old in terms of clinical cure, defined by apyrexia AND no abdominal pain AND no feeding problem at the medical visit. .
Recurrence of AP
Demonstrate the non-inferiority of a 3-day IV antibiotic treatment versus a 3-day IV/IM followed by 7-day oral antibiotic treatment for AP in children 1 month to 3 years old in terms of recurrence (including AP relapse or reinfection) of acute pyelonephritis
Colonization with antimicriobial-resistant Enterobacteriaceae
Compare between the two treament arms the rate of colonization with antimicrobial-resistant Enterobacteriaceae in the gastrointestinal tract
Bacterial diversity of the intestinal microbiota
Compare between the two treament arms the bacterial diversity of the intestinal microbiota : alpha-diversity measured by Shannon's index.

Full Information

First Posted
September 14, 2022
Last Updated
October 11, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05544565
Brief Title
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Acronym
PYELOCOURT
Official Title
3-day Intravenous Antibiotic Treatment Versus 3-day Intravenous Followed by 7-day Oral Antibiotic Treatment for Acute Pyelonephritis in Children 1 Month to 3 Years Old: a Non-inferiority Open Randomized Multicentric Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 therapy to prevent long-term renal scarring. The investigators also hypothesize that while achieving equivalent clinical and microbiological success, 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.
Detailed Description
1.0 Hypothesis for the study 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 therapy to prevent long-term renal scarring. The investigators also hypothesize that while achieving equivalent clinical and microbiological success, 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. 2.0 Description of knowledge relating to the condition in question Acute pyelonephritis (AP) is the most common proven bacterial infection in pediatric clinical practice. It can lead to sepsis or renal abscess and induce long-term complications such as renal scarring. Renal scarring during childhood can lead to hypertension or chronic renal disease at adult age, although the link between AP and chronic renal disease has not been firmly established. AP is most frequently due to Enterobacteriaceae, mainly Escherichia coli. Extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) now account for 5% of AP in France and represent a serious threat to public health, owing to limited therapeutic options. The overall clinical success rate in children treated for AP is around 95% and is not significantly different when ESBL-E are implicated. In children with no prior urological malformation, recurrence in the following 3 months occurs in less than 5% of cases. Antibiotic treatment decreases the risk of renal scarring, which remains important, around 15% (95% CI: 11-18) in the largest meta-analysis. Moreover, delay in treatment of AP is associated with permanent renal scarring. In children without prior urological malformation, acute complications are exceptional, even in the presence of bacteraemia. Short courses of intravenous (IV) antibiotics (2-4 days) followed by oral therapy have proved to be as efficient as longer courses (7-14 days) of IV treatment. For children aged ≥ 1 month, oral treatment alone for 10 to 14 days has proved non inferior to initial IV antibiotics (2-4 days) followed by oral therapy (total 10 to 14 days). French Paediatric guidelines recommend a short course (up to 4 days) of IV amikacin and/or ceftriaxone followed by oral therapy (total 10 days), with the possibility, for children aged > 3 months of a 10-day course of oral cefixime [12]. In children initially treated IV, the oral relay occurs once the urine culture and antibiogram are available. The American Association of Pediatrics that focused on children aged 2 to 24 months recommends either an oral or a sequential IV/oral treatment for a total of 7 to 14 days, while the British NICE guidelines recommend an exclusively oral route only for children aged ≥ 3 months In practice, most centers initiate an IV treatment in a large subset of patients (ongoing practice analysis on the management of AP in children in France, personal data, to be published in 2021). An initial IV treatment is particularly used in young children, with an age cut-off varying between 3 months and 3 years according to the center. It is also used to secure the absorption of the treatment if the child vomits, is unable to take oral antibiotics or is severely unwell. The excellent short-term and the good long-term clinical outcomes in children treated for AP questions the need for a 10-day course of antibiotics. In adults, shorter treatments, such as amikacin for 5 days, have been validated for the treatment of uncomplicated AP. Since the publication of studies demonstrating the non-inferiority of oral vs IV treatment, no 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.gov) comparing a 5-day vs a 10-day oral treatment for urinary tract infection in children between 2 months and 5 years (NCT04400110), or a 7-day vs a 10-day oral treatment in children between 3 months and 7 years old (NCT03221504). A third controlled clinical trial (NCT01595529) has ended its inclusions ad performed analysis but not yet published in a peer-reviewed journal: it compared a 5-day vs a 10-day oral treatment for urinary tract infection (febrile or not) in children between 2 months and 10 years old. Both treatments resulted in high success rates (> 96%). The 5-day treatment tended to be inferior to the 10-day one (p=0.054). However, the study allowed 4 different oral therapies (Trimethoprim sulfamethoxazole, Cefixime, Cefdinir or Cephalexin) and results for each subgroup are not yet available. Moreover, antibiotic treatments modify the diversity of the gut microbiota. These disturbances, described as dysbiosis, are generally transient, but can lead to a lasting and stable modification of the gut microbiota, and be involved in the occurrence of chronic diseases in children as in adults. Third-generation cephalosporins (3GC), such as ceftriaxone, rapidly reduce the richness and diversity of the gut microbiota and also select subpopulations of resistant bacteria, particularly by acquisition of extended spectrum beta-lactamases, a major public health issue. There is no data on the impact of antibiotic relays on the gut microbiota. Since each antibiotic has its own anti-bacterial spectrum, a sequence of treatments could have an additive or even synergistic deleterious effect on the gut microbiota. This may in particular be the case in children treated with IV ceftriaxone for 3 days followed by cotrimoxazole for 7 days, as recommended in France in first intention. 3.0 Summary of relevant pre-clinical experiments and clinical trials 1999 Hoberman et al. Oral versus initial intravenous therapy for urinary tract infections in young febrile children This was a non-inferiority study between oral cefixime for 14 days and intravenous ceftriaxone for 3 days followed by oral cefixime for 11 days. One of the outcomes was the occurrence of renal scarring. It included children aged 1 to 24 months. A total of 306 children were included. Renal scarring at 6 months was noted in 9.8% children treated orally versus 7.2% of children treated intravenously. The study conclude that oral treatment was safe. The main limit of the study was the lower rate of renal scar in both arms compared to other studies, probably linked to a female/male sex ratio of 9:1 (with a median age of 8 months), when the sex ratio is in favour of boys before 1-year-old. 2007, Montini et al. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial This was a multicentre, randomised controlled, open labelled, parallel group, non-inferiority trial comparing oral co-amoxiclav for 10 days to parenteral ceftriaxone for three days, followed by oral co-amoxiclav for 7 days. Primary outcome was the rate of renal scarring after 12 months. A total of 502 children aged 1 month to <7 years with clinical pyelonephritis were included. Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome (scarring scintigraphy at 12 months 27/197 (13.7%) v 36/203 (17.7%), and secondary outcomes: time to defervescence, white cell count at day 3, and percentage with sterile urine at day 3 (99.5% n both arms). The results were similar in the subgroups of children older and younger than 2 years (data not shown in the paper). 2012, Boquet et al. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children PHRC AOM 04 105; NCT00136656 This was a non-inferiority study between oral cefixime for 10 days and IV ceftriaxone for 4 days followed by oral cefixime for 6 days on the occurrence of renal scarring. It included children aged 1 to 36 mont with a first proven urinary tract infection and procalcitonin concentration ≥ 0.5 ng/mL s. The primary endpoint was the proportion of renal scar measured by 99mTc-DMSA renal scintigraphy 6 to 8 months after treatment. The study included a total 171 children of the 698 expected. The incidence of renal scarring was 30.8% in the oral treatment group and 27.3% for children who received the sequential treatment. The trial could not demonstrate statistically the non-inferiority due to insufficient enrolment. Comment: The protocol was demanding for participants: each child had a first 99mTc-DMSA renal scintigraphy upon diagnosis, and for those with abnormal scintigraphy, a second 6 to 8 months later to evaluate renal scar. All children also had a voiding cystography. The 99mTc-DMSA scintigraphy to measure renal scarring led to fewer than 12% lost to follow. The association of 2 9mTc-DMSA renal scintigraphy probably limited the acceptance of the protocol, which explains that we chose to perform only one scintigraphy at the end of the evaluation. The higher renal scarring than in the study by Montini et al may in part be explained by the additional inclusion criteria of a procalcitonin concentration ≥ 0.5 ng/mL, a level being associated with renal scars

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyelonephritis Acute
Keywords
Pyelonephritis acute, Antibiotic therapies, Renal scar, Paediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open, multicentric, parallel group non-inferiority clinical trial with 1:1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: Discontinuation of treatment
Arm Type
Experimental
Arm Description
For patients randomized in the experimental group, the patient receives 3-day IV therapy and the treatment is interrupted.
Arm Title
Control group: Usual practice
Arm Type
Other
Arm Description
For patients randomized in the control group, the treatment for acute pyelonephritis is based on the attending clinician's practice and according to the usual practice: 3-day IV therapy followed by a 7-day oral antibiotic therapy.
Intervention Type
Drug
Intervention Name(s)
IV Antibacterial Agents
Intervention Description
Ceftriaxone (50 mg/kg once a day by intravenous/intramuscular route) AND/OR Amikacin (20 mg/kg once a day by intravenous/intramuscular route) during 3 days. .
Intervention Type
Drug
Intervention Name(s)
Orally antibacterial agents
Intervention Description
Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days
Intervention Type
Procedure
Intervention Name(s)
Fecal/Rectal Swab
Intervention Description
Collected by the nurse or the physician (D0,D3,D14) (and parents for D45), either by a rectal swab, either by fecal swab (dip of the swab in fresh stools < 4 hours, which will occur frequently in our population of children aged 1 month to 3 years, and will in particular be possible for hospitalized children) using a FecalSwabTM, that contains a transport medium.
Intervention Type
Procedure
Intervention Name(s)
PCT assay
Intervention Description
Dosage of procalcitonin (if not performed in standard care) at D0
Intervention Type
Procedure
Intervention Name(s)
Renal scintigraphy
Intervention Description
A DMSA scintigraphy (99mTc-DMSA) will be performed at 6 months (± 15 days) for evaluation of the kidney growth and renal scars
Primary Outcome Measure Information:
Title
Occurrence of renal scarring
Description
Demonstrate the non-inferiority of a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy for the treatment of AP in children in term of the occurrence of renal scarring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy
Time Frame
180 days (± 15 days) after the beginning of therapy
Secondary Outcome Measure Information:
Title
Clinical cure
Description
Demonstrate the non-inferiority of a 3-day IV antibiotic treatment versus a 3-day IV followed by 7-day oral antibiotic treatment for AP in children 1 month to 3 years old in terms of clinical cure, defined by apyrexia AND no abdominal pain AND no feeding problem at the medical visit. .
Time Frame
14 days (± 3 days) after the beginning of therapy
Title
Recurrence of AP
Description
Demonstrate the non-inferiority of a 3-day IV antibiotic treatment versus a 3-day IV/IM followed by 7-day oral antibiotic treatment for AP in children 1 month to 3 years old in terms of recurrence (including AP relapse or reinfection) of acute pyelonephritis
Time Frame
90 days after the beginning of therapy
Title
Colonization with antimicriobial-resistant Enterobacteriaceae
Description
Compare between the two treament arms the rate of colonization with antimicrobial-resistant Enterobacteriaceae in the gastrointestinal tract
Time Frame
days of randomization and 14 days after the beginning of therapy
Title
Bacterial diversity of the intestinal microbiota
Description
Compare between the two treament arms the bacterial diversity of the intestinal microbiota : alpha-diversity measured by Shannon's index.
Time Frame
Inclusion, randomization and 14 days after the beginning of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 1 month and < 3 years For children younger than 3 months, gestational age > 34 WA First episode of urinary tract infection AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 10^4/mL) Initial treatment by either ceftriaxone AND/OR amikacin Outpatient or hospitalised Non-inclusion Criteria: Urine collected by bag Urine culture growing more than one dominant bacterium (cf section 6.2 of the protocol) Catheter-associated AP Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm) Previous surgery of the genitourinary tract (except circumcision in 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 condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents) Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP) Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (include cephalosporin et beta-lactams) and amikacin (include aminoside) Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (include sulfonamide) and cefixime (include cephalosporin) Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy) Known severe hepatic insufficiency Known G6PD deficiency No written consent from holders of parental authority Non-affiliation to a social security system (as beneficiary or entitled person) Children whose follow-up is not carried out in the centre Participation in another interventional or minimal risk trial Randomization criteria : Three days of taking antibiotics (IV or IM) (no interruption or discontinuation) Positive urine culture with Gram negative bacillus ≥ 10^4 UFC/mL Favorable clinical outcome at day of randomization (D2 or D3) defined by temperature < 38°C at day of randomization and absence of fever measured > 38°C for at least 12 hours AND no abdominal pain AND no feeding problem AND investigator agreement No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm) on the renal ultrasound performed between D0 and day of randomization No more than 1 type of dominant bacteria on the urine culture Sensitivity to the initial antibiotic treatment Sensitivity to cefixime OR cotrimoxazole
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean GASCHIGNARD, PhD
Phone
+33 1 65 54 33 92
Email
j.gaschignard@ghne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Romain BASMACI, PhD
Phone
+33 1 47 60 63 58
Email
romain.basmaci@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean GASCHIGNARD, PhD
Organizational Affiliation
Groupe Hospitalier Nord-Essonne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Sud Francilien
City
Corbeil-Essonnes
State/Province
Essonne
ZIP/Postal Code
91100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Rouget, Dr
Facility Name
Logjumeau hospital
City
Longjumeau
State/Province
Essonne
ZIP/Postal Code
91160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Gaschignard, PhD
Facility Name
Orsay hospital
City
Orsay
State/Province
Essonne
ZIP/Postal Code
91400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Gaschignard, PhD
Facility Name
Caremeau hospital
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Filleron, Dr
Facility Name
Antoine Beclère Hospital
City
Clamart
State/Province
Haut De Seine
ZIP/Postal Code
92140
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Gajdos, Pr
Facility Name
Children hospital
City
Toulouse
State/Province
Haute Garpnne
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Brehin, Dr
Facility Name
Ambroise Paré hospital
City
Boulogne
State/Province
Hauts De Seine
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Soussan, Dr
Facility Name
Arnaud de villeneuve Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Jeziosrki, Pr
Facility Name
Arnaud de Villeneuve hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëlle Tourniaire, Dr
Facility Name
Children-Teenager hospital
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Launay, Pr
Facility Name
Jeanne Flandre Hospital
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Dubos, Pr
Facility Name
Meaux Hospital
City
Meaux
State/Province
Seine Et Marne
ZIP/Postal Code
77100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Vignaud, Dr
Facility Name
Charles Nicole Hospital
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Pinquier, Dr
Facility Name
Jean Verdier Hospital
City
Bondy
State/Province
Seine Saint Denis
ZIP/Postal Code
93140
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien Galerne, Dr
Facility Name
Delafontaine Hospital
City
Saint-Denis
State/Province
Seine Saint Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Escoda, Dr
Facility Name
Intercomunal Créteil Hospital
City
Créteil
State/Province
Val De Marne
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fouad Madhi, Dr
Facility Name
Kremlin Bicêtre Hospital
City
Le Kremlin-Bicêtre
State/Province
Val De Marne
ZIP/Postal Code
94270
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Auger, Dr
Facility Name
Andre mignot hospital
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Nathanson, Dr
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Faye, Pr
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Rybak, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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