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Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome (GRAAL)

Primary Purpose

Short Bowel Syndrome, Infection, Bacterial

Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Amoxicillin
Levofloxacin
Ofloxacin
Sulfamethoxazole trimethoprim
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Short bowel syndrome
  • Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
  • Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
  • Affiliated to a social security system
  • Having received an physical examination before entering study
  • Having received full information regarding the study organization and having signed the informed consent

Exclusion Criteria:

  • Patient at risk of worsening their oral absorption abilities during study
  • Patient requiring dialysis
  • Women of childbearing age without efficient birth control
  • Allergy to any of the drugs tested
  • Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
  • Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1

Sites / Locations

  • CHRU NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Amoxicillin

Ofloxacin

Levofloxacin

Sulfamethoxazole trimethoprim

Arm Description

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Outcomes

Primary Outcome Measures

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

Secondary Outcome Measures

Describe antibiotic absorption after oral administration in these patients
Peak plasma concentration (Cmax) after oral intake
Describe antibiotic absorption after oral administration in these patients
Peak plasma concentration time after oral intake (Tmax)
Describe antibiotic absorption after oral administration in these patients
Area under the plasma concentration versus time curve (AUC)
Assess link between length of remaining bowel and antibiotic absorption
Length of remaining bowel (cm)

Full Information

First Posted
March 2, 2022
Last Updated
February 10, 2023
Sponsor
Central Hospital, Nancy, France
Collaborators
Société Francophone Nutrition Clinique et Métabolisme, FIlière des Maladies rares Abdomino-THOraciques, Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT05302531
Brief Title
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
Acronym
GRAAL
Official Title
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Société Francophone Nutrition Clinique et Métabolisme, FIlière des Maladies rares Abdomino-THOraciques, Fresenius Kabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.
Detailed Description
When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome, Infection, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Experimental
Arm Description
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
Arm Title
Ofloxacin
Arm Type
Experimental
Arm Description
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
Arm Title
Levofloxacin
Arm Type
Experimental
Arm Description
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
Arm Title
Sulfamethoxazole trimethoprim
Arm Type
Experimental
Arm Description
Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Intervention Description
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole trimethoprim
Intervention Description
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Primary Outcome Measure Information:
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time -0.5 hours
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +0.5 hours
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +1 hour
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +1.5 hour
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +2 hours
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +4 hours
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +6 hours
Title
Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
Description
F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
Time Frame
Time +8 hours
Secondary Outcome Measure Information:
Title
Describe antibiotic absorption after oral administration in these patients
Description
Peak plasma concentration (Cmax) after oral intake
Time Frame
Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Title
Describe antibiotic absorption after oral administration in these patients
Description
Peak plasma concentration time after oral intake (Tmax)
Time Frame
Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Title
Describe antibiotic absorption after oral administration in these patients
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
Title
Assess link between length of remaining bowel and antibiotic absorption
Description
Length of remaining bowel (cm)
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Short bowel syndrome Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy Affiliated to a social security system Having received an physical examination before entering study Having received full information regarding the study organization and having signed the informed consent Exclusion Criteria: Patient at risk of worsening their oral absorption abilities during study Patient requiring dialysis Women of childbearing age without efficient birth control Allergy to any of the drugs tested Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niasha MICHOT, MD
Phone
+33383155108
Email
n.michot@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Pape
Email
e.pape@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niasha MICHOT, MD
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
State/Province
Lorraine
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niasha MICHOT, MD
Phone
+33383155108
Email
n.michot@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Julie LECOMTE
Phone
+33383155278
Email
ju.lecomte@chru-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on first results, this pilot study might be extended in a new multicenter study
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Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome

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