PyelonephritisPhase 4NCT00136656
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
A Phase 4 study testing antibiotic and antibiotics in people with Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Pyelonephritis
- What is being tested?
- antibiotic and antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 12 sitesFrance
- Study dates
- Jul 2005to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 +
Show all 10Show fewer
- Normal hemodynamic exam
- Normal renal ultrasonography
- Positive DMSA renal scan for pyelonephritis during the first week after diagnosis
- Parental informed consent
Who cannot join
- 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
Show all 10Show fewer
- Antibiotic during the five previous days
- Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption
- Absence of parental consent
- Social familial difficulties
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hopital de Bicetre
Bicêtre, 94275
Hopital Pellegrin
Bordeaux, 33000
Hôpital Ambroise Pare
Boulogne, 92100
Hôpital Antoine Beclere
Clamart, 92141
Chu de Limoges
Limoges, 87042
La Timone
Marseille, 13385
CHU NICE
Nice, 06000
Saint Vincent de Paul
Paris, 75014
Necker Enfants Malades
Paris, 75015
Robert Debre
Paris, 75019
Hôpital Armand Trousseau
Paris, 75571
Hopital Andre Mignot
Versailles, 78150
About this study
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.
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.
Read the 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.
- Conditions
- Pyelonephritis
- Being tested
- antibiotic, antibiotics
- Keywords
- infant, children, pyelonephritis, Renal scars, DMSA scan
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibioticDrug
cephalosporine by oral route : cefixime
antibioticsDrug
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cefixime antibiotic treatment by oral route Receives: Drug: antibiotic |
| 2 | Sham comparator | ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days Receives: Drug: antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
Measured: between six and eight months
Secondary outcomes (2)
Time to get apyrexia
Measured: 4 days
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PyelonephritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- CHERON GERARD, MD, Principal investigator, Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5CHEVALLIER BERTRAND, MD, Study chair, Ambroise Paré Hospital, Assistance Publique Hôpitaux de ParisGAJDOS VINCENT, MD, Study chair, Antoine Béclère Hospital Assistance Publique Hôpitaux de ParisLABRUNE PHILIPPE, MD, Study chair, Antoine Béclère Hospital Assistance Publique Hôpitaux de ParisGRIMPREL EMMANUEL, MD, Study chair, Trousseau Hospital AP HPDESCHENES GEORGES, MD, Study chair, TROUSSEAU HOSPITAL AP-HPSERGENT ALINE, MD, Study chair, TROUSSEAU HOSPITAL AP-HPVAYLET CLAIRE, MD, Study chair, TROUSSEAU HOSPITAL AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136656
- Sponsor's protocol ID
- P040422
- Other IDs
- AOM 04 105
- Status last verified
- Feb 2009
- First submitted
- 26 Aug 2005
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sannier N, Le Masne A, Sayegh N, Gaillard JL, Cheron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. No abstract available.
PubMed 10772296Leroy S, Marc E, Adamsbaum C, Gendrel D, Breart 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. doi: 10.1136/adc.2004.068205. Epub 2005 May 12.
PubMed 15890693Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Breart 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. doi: 10.1542/peds.2004-1631. Epub 2005 May 2.
PubMed 15867014Marc E, Menager C, Moulin F, Stos B, Chalumeau M, Guerin 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. doi: 10.1016/s0929-693x(01)00793-x. French.
PubMed 11998420Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Cheron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.
PubMed 22291112
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00136656
- Acronym / sponsor ID
- P040422
- Conditions
- Pyelonephritis
- Keywords
- infant, children, pyelonephritis, Renal scars, DMSA scan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: antibioticcefixime antibiotic treatment by oral route |
| 2 | Sham comparator | Drug: antibioticsceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- Newborn
- Children more than 3 years old
- Past urine infection
- Septic hemodynamic abnormalities
- Obstructive uropathy and any renal ultrasonography abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibioticcephalosporine by oral route : cefixime | Drug | 1 |
| antibioticscephalosporine : ceftriaxone by intra venous route and cefixime by oral route | Drug | 2 |
Primary outcome
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
Time frame: between six and eight months
2 secondary outcomes
Time to get apyrexia
Time frame: 4 days
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- Background: PubMed 10772296Sannier N, Le Masne A, Sayegh N, Gaillard JL, Cheron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. No abstract available.
- Background: PubMed 15890693Leroy S, Marc E, Adamsbaum C, Gendrel D, Breart 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. doi: 10.1136/adc.2004.068205. Epub 2005 May 12.
- Background: PubMed 15867014Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Breart 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. doi: 10.1542/peds.2004-1631. Epub 2005 May 2.
- Background: PubMed 11998420Marc E, Menager C, Moulin F, Stos B, Chalumeau M, Guerin 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. doi: 10.1016/s0929-693x(01)00793-x. French.
- Derived from this study: PubMed 22291112Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Cheron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHERON GERARD, MD principal investigator
Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5
CHEVALLIER BERTRAND, MD study chair
Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris
GAJDOS VINCENT, MD study chair
Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antibiotic and antibiotics in people with Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months (time frame: between six and eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136656, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.