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NCT Number: NCT05302531

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

The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.

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Key information

Conditions

Short Bowel Syndrome Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gastrointestinal Diseases Infection, Bacterial Infections Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Levofloxacin

Drug

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Ofloxacin

Drug

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Sulfamethoxazole trimethoprim

Drug

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Primary outcomes

  1. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time -0.5 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  2. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +0.5 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  3. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +1 hour

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  4. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +1.5 hour

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  5. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +2 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  6. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +4 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  7. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +6 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

  8. Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

    Time frame: Time +8 hours

    F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)

Secondary outcomes

  1. Describe antibiotic absorption after oral administration in these patients

    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

    Peak plasma concentration (Cmax) after oral intake

  2. Describe antibiotic absorption after oral administration in these patients

    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

    Peak plasma concentration time after oral intake (Tmax)

  3. Describe antibiotic absorption after oral administration in these patients

    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

    Area under the plasma concentration versus time curve (AUC)

  4. Assess link between length of remaining bowel and antibiotic absorption

    Time frame: At inclusion

    Length of remaining bowel (cm)

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Pape

CONTACT

[email protected]

Niasha MICHOT, MD

CONTACT

[email protected]

+33383155108

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • FIlière des Maladies rares Abdomino-THOraciques
  • Fresenius Kabi
  • Société Francophone Nutrition Clinique et Métabolisme

Registry information

Official study title

Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study

Acronym: GRAAL

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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