Efficacy and Pharmacokinetic/Pharmacodynamic Parameters of Cefoxitin in Women With Acute Pyelonephritis Without Severity Symptoms Due to Extended-spectrum β-lactamase Producing Escherichia Coli (FOXICOLI)
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|ClinicalTrials.gov Identifier: NCT01820793|
Recruitment Status : Terminated (Not enought inclusion)
First Posted : March 29, 2013
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Pyelonephritis Without Severity Symptoms Due to ESBL-producing E.Coli||Drug: Cefoxitin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Pharmacokinetic/Pharmacodynamic Parameters of Cefoxitin in Women With Acute Pyelonephritis Without Severity Symptoms Due to Extended-spectrum β-lactamase Producing Escherichia Coli.|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||November 2015|
this study is centered on women with pyelonephritis without severity symptoms due to ESBL-producing E. coli.
proof of concept study to evaluate the efficacy of cefoxitin (2 grams every 6 hours for 10 days) in 40 women presenting acute ESBL-producing E.coli pyelonephritis without severity symptoms and to perform on half of the participants repeated measurements of cefoxitin serum levels (6 blood samples within 6 hours following an injection).
- To assess Clinical and microbiological response [ Time Frame: 10 days ]Clinical and microbiological response defined at the end of cefoxitin treatment by the presence of the 3 following criteria: (i) afebrile (temperature > 36°C and < 38°C), (ii) resolution of urinary symptoms present at the time of diagnosis: dysuria, urgency, frequency, cloudy urine, pain on urination, pelvic or lumbar pain (iii) sterile urine culture.
- To detect of cefoxitin resistant strains [ Time Frame: 40±5 days ]detection of cefoxitin resistant strains colonising the gastrointestinal tract of women with pyelonephritis before treatment with cefoxitin, emergence of resistance under treatment and determination of associated mechanisms of resistance to cefoxitin
- To assess the bacteriological Relapse [ Time Frame: 40 days ]Early relapse at day 40 defined by clinical and microbiological success at 10 days and absence of clinical signs at 40 days
- To evaluate Clinical and microbiological response [ Time Frame: 48 h ]Clinical and microbiological response at 48h after beginning treatment with cefoxitin
- to measure the Pharmacokinetic parameters [ Time Frame: 48 h ]measure of total clearance of elimination and Measure of the volume of distribution
- Measure of efficacy of cefoxitin [ Time Frame: 10 days ]side effects of cefoxitin all days
- To measure the Pharmacodynamic parameters [ Time Frame: 48 h ]PD parameters;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820793
|Clichy, France, 92110|
|Principal Investigator:||Agnès LEFORT, Pr||Assistance Publique - Hôpitaux de Paris|