Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00136656
Other study ID # P040422
Secondary ID AOM 04 105
Status Completed
Phase Phase 4
First received August 26, 2005
Last updated February 11, 2009
Start date July 2005
Est. completion date February 2009

Study information

Verified date February 2009
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date February 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 3 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
antibiotic
cephalosporine by oral route : cefixime
antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Locations

Country Name City State
France Hopital de Bicetre Bicetre
France Hopital Pellegrin Bordeaux
France Hôpital Ambroise Pare Boulogne
France Hôpital Antoine Beclere Clamart
France Chu de Limoges Limoges
France La Timone Marseille
France CHU NICE Nice
France Hôpital Armand Trousseau Paris
France Necker Enfants Malades Paris
France Robert Debre Paris
France Saint Vincent de Paul Paris
France Hopital Andre Mignot Versailles

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Bréart G, Chalumeau M. Procalcitonin as a predictor of vesicoureteral reflux in children with a first febrile urinary tract infection. Pediatrics. 2005 Jun;115(6):e706-9. Epub 2005 May 2. — View Citation

Leroy S, Marc E, Adamsbaum C, Gendrel D, Bréart G, Chalumeau M. Prediction of vesicoureteral reflux after a first febrile urinary tract infection in children: validation of a clinical decision rule. Arch Dis Child. 2006 Mar;91(3):241-4. Epub 2005 May 12. — View Citation

Marc E, Ménager C, Moulin F, Stos B, Chalumeau M, Guérin S, Lebon P, Brunet F, Raymond J, Gendrel D. [Procalcitonin and viral meningitis: reduction of unnecessary antibiotics by measurement during an outbreak]. Arch Pediatr. 2002 Apr;9(4):358-64. French. — View Citation

Sannier N, Le Masne A, Sayegh N, Gaillard JL, Chéron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months between six and eight months No
Secondary Time to get apyrexia 4 days Yes
Secondary Incidence of urologic abnormalities on cystourethrography done during the first month after the infection one month Yes
See also
  Status Clinical Trial Phase
Completed NCT03282006 - Treating Pyelonephritis an Urosepsis With Pivmecillinam Phase 4
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT03275623 - Management of Sub-Clinical Bacteriuria in Pregnancy Phase 4
Completed NCT00210886 - A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis. Phase 3
Completed NCT00528476 - Risk Factors for Recurrent Urinary Tract Infection in Children N/A
Completed NCT03873701 - Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
Completed NCT00382343 - A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux Phase 4
Recruiting NCT03959163 - The Validity of the Quick Renal MRI in Pediatric Kidney Disease N/A
Completed NCT01861353 - Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children N/A
Terminated NCT01628900 - Prospective Study in the Emergency Phase 2
Completed NCT01505634 - Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003) Phase 2
Not yet recruiting NCT06128213 - NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis Phase 2
Completed NCT00210990 - Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis Phase 3
Completed NCT01345929 - Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis Phase 3
Completed NCT00258089 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections Phase 3
Completed NCT01641029 - Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis N/A
Terminated NCT00724256 - Short-term Antibiotic Therapy for Pyelonephritis in Childhood Phase 3
Completed NCT04594161 - Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis N/A
Completed NCT02080182 - Effect of Acetylcysteine in Pediatric Acute Pyelonephritis. Phase 2