Patient with short bowel syndrome treated with antibiotics for urinary parenchymal infection MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: AMOXICILLINE
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Centre Hospitalier Régional Universitaire de Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years of age ; ; 2. Patient with short bowel syndrome 3. Patient treated for urinary parenchymal infection (pyelonephritis / prostatitis) (documented with antibiogram) with SULFAMETHOXAZOLE/TRIMETHOPRIME / AMOXICILLINE (+/- acide clavulanique)/ OFLOXACINE / LEVOFLOXACINE 4. Patient hospitalized in the Nutritional Assistance Unit or in the Infectious and Tropical Diseases Department 5. Patient affiliated with to beneficiary of a social security system; 6. Patient having performed a preliminary clinical examination 7. Patient who signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient at foreseeable risk of degrading their PO absorption capacity during follow-up; 2. Patient on dialysis; 3. Female of childbearing age without effective contraception; 4. Person with a known allergy to one of the components of the evaluated product; 5. Person with a contraindication to (or one of the) evaluated product (s); 6. Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: o Pregnant women, parturient women or nursing mothers ; o Minor (non-emancipated) o Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard); o Adults person who is unable to give consent and who is not subject to a legal protection measure; o Persons deprived of their liberty by a judicial or administrative decision; o Persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the absolute oral bioavailability of antibiotics in patients with short bowel;Secondary Objective: 1) Describe the absorption of antibiotics after PO administration in these patients. 2) Evaluate the link between remaining hail length and antibiotic absorption.;Primary end point(s): Measurement of the absolute bioavailability of the Per Os form calculated according to the following formula : F (%)=(AUC PO)/(AUC IV) x (Dose IV)/(Dose PO) AUC : Area under the curve (0h to 8h) NB: The intravenous data and the per os data are from the same patient, which makes it possible to match using this formula.;Timepoint(s) of evaluation of this end point: The bioavailability of antibiotics taken in oral form will be measured by assaying the antibiotics in blood samples taken at different times (at T- 0.5h; T + 0.5h, T + 1h, T + 1.5h T + 2h, T + 4h, T + 6h, T + 8h (T = time of oral intake of the PO antibiotic). i.e. 8 hours after the last oral intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Describe the pharmacokinetic parameters after PO administration of antibiotics in these patients: • Maximum concentration after PO (Cmax) • Time required to obtain Cmax after PO (Tmax) 2) Evaluate the link between remaining hail length and antibiotic absorption: • Length of hail remaining • Carmine red test time • Maximum concentration after PO (Cmax) • Time required to obtain Cmax after PO (Tmax);Timepoint(s) of evaluation of this end point: Secondary end points will be assessed after taking oral antibiotics | — |
Countries
France
Contacts
Public ContactStudy Project Manager
Centre Hospitalier Régional Universitaire de Nancy
Outcome results
None listed