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Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old

Primary Purpose

Pyelonephritis

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

antibiotic

antibiotics

About this trial

This is an interventional treatment trial for Pyelonephritis focused on measuring infant, children, pyelonephritis, Renal scars, DMSA scan

Eligibility Criteria

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

Inclusion Criteria: Infants and children more than 1 month old and less than 3 years old First episode of acute pyelonephritis with gram negative strains Fever more than 38.5°C Procalcitonin (PCT) value > 0.5 ng/ml Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection Urine exam: more than 100.000 leukocytes and gram negative strains + Normal hemodynamic exam Normal renal ultrasonography Positive DMSA renal scan for pyelonephritis during the first week after diagnosis Parental informed consent Exclusion Criteria: Newborn Children more than 3 years old Past urine infection Septic hemodynamic abnormalities Obstructive uropathy and any renal ultrasonography abnormalities Allergy to cefixime or ceftriaxone Antibiotic during the five previous days Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption Absence of parental consent Social familial difficulties

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

cefixime antibiotic treatment by oral route

ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Outcomes

Primary Outcome Measures

Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months

Secondary Outcome Measures

Time to get apyrexia

Incidence of urologic abnormalities on cystourethrography done during the first month after the infection

Full Information

NCT ID

NCT00136656

First Posted

August 26, 2005

Last Updated

February 11, 2009

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00136656

Brief Title

Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old

Official Title

Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d. Multicenter, Randomised Trial of Equivalence.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode. The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.

Detailed Description

Guidelines for treatment of acute pyelonephritis in infants and children are different from one country to another. The main question is the incidence of renal scars. intravenous route (IV) treatment is supposed to give the best results, but no previous study has ever given the incidence of renal scars after PO treatment. This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pyelonephritis

Keywords

infant, children, pyelonephritis, Renal scars, DMSA scan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

700 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

cefixime antibiotic treatment by oral route

Arm Title

Arm Type

Sham Comparator

Arm Description

ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Intervention Type

Drug

Intervention Name(s)

antibiotic

Intervention Description

cephalosporine by oral route : cefixime

Intervention Type

Drug

Intervention Name(s)

antibiotics

Intervention Description

cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Primary Outcome Measure Information:

Title

Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months

Time Frame

between six and eight months

Secondary Outcome Measure Information:

Title

Time to get apyrexia

Time Frame

4 days

Title

Incidence of urologic abnormalities on cystourethrography done during the first month after the infection

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: