Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136656
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2005-08-26
Brief Title:
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 routeIV 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM 04 105 | None | None | None |