NCT05302531

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

March 2, 2022

Last Update Submit

August 28, 2024

Conditions

Short Bowel SyndromeInfection, Bacterial

Outcome Measures

Primary Outcomes (8)

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

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

    Time -0.5 hours

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

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

    Time +0.5 hours

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

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

    Time +1 hour

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

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

    Time +1.5 hour

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

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

    Time +2 hours

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

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

    Time +4 hours

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

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

    Time +6 hours

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

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

    Time +8 hours

Secondary Outcomes (4)

  • Describe antibiotic absorption after oral administration in these patients

    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

  • Describe antibiotic absorption after oral administration in these patients

    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

  • Describe antibiotic absorption after oral administration in these patients

    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

  • Assess link between length of remaining bowel and antibiotic absorption

    At inclusion

Study Arms (4)

Amoxicillin

EXPERIMENTAL

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.

Drug: Amoxicillin

Ofloxacin

EXPERIMENTAL

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.

Drug: Ofloxacin

Levofloxacin

EXPERIMENTAL

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.

Drug: Levofloxacin

Sulfamethoxazole trimethoprim

EXPERIMENTAL

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.

Drug: Sulfamethoxazole trimethoprim

Interventions

AmoxicillinDRUG

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

Amoxicillin
LevofloxacinDRUG

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

Levofloxacin
OfloxacinDRUG

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

Ofloxacin
Sulfamethoxazole trimethoprimDRUG

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

Sulfamethoxazole trimethoprim

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

Related Publications (15)

  • Scala-Bertola J, Rabiskova M, Lecompte T, Bonneaux F, Maincent P. Granules in the improvement of oral heparin bioavailability. Int J Pharm. 2009 Jun 5;374(1-2):12-6. doi: 10.1016/j.ijpharm.2009.02.020. Epub 2009 Mar 9.

    PMID: 19446753BACKGROUND

  • American Gastroenterological Association. American Gastroenterological Association medical position statement: short bowel syndrome and intestinal transplantation. Gastroenterology. 2003 Apr;124(4):1105-10. doi: 10.1053/gast.2003.50139. No abstract available.

    PMID: 12671903BACKGROUND

  • Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM; Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016 Apr;35(2):247-307. doi: 10.1016/j.clnu.2016.01.020. Epub 2016 Feb 8.

    PMID: 26944585BACKGROUND

  • Gupta A, Mehta Y, Juneja R, Trehan N. The effect of cannula material on the incidence of peripheral venous thrombophlebitis. Anaesthesia. 2007 Nov;62(11):1139-42. doi: 10.1111/j.1365-2044.2007.05180.x.

    PMID: 17924895BACKGROUND

  • Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159.

    PMID: 16970212BACKGROUND

  • Ward N. The impact of intestinal failure on oral drug absorption: a review. J Gastrointest Surg. 2010 Jun;14(6):1045-51. doi: 10.1007/s11605-009-1151-9. Epub 2010 Jan 22.

    PMID: 20094812RESULT

  • Vance-Bryan K, Guay DR, Rotschafer JC. Clinical pharmacokinetics of ciprofloxacin. Clin Pharmacokinet. 1990 Dec;19(6):434-61. doi: 10.2165/00003088-199019060-00003.

    PMID: 2292168RESULT

  • Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004.

    PMID: 1559306RESULT

  • Barr WH, Zola EM, Candler EL, Hwang SM, Tendolkar AV, Shamburek R, Parker B, Hilty MD. Differential absorption of amoxicillin from the human small and large intestine. Clin Pharmacol Ther. 1994 Sep;56(3):279-85. doi: 10.1038/clpt.1994.138.

    PMID: 7924123RESULT

  • Severijnen R, Bayat N, Bakker H, Tolboom J, Bongaerts G. Enteral drug absorption in patients with short small bowel : a review. Clin Pharmacokinet. 2004;43(14):951-62. doi: 10.2165/00003088-200443140-00001.

    PMID: 15530127RESULT

  • Cheung YW, Barco S, Mathot RAA, van den Dool EJ, Stroobants AK, Serlie MJ, Middeldorp S, Coppens M. Pharmacokinetics of dabigatran etexilate and rivaroxaban in patients with short bowel syndrome requiring parenteral nutrition: The PDER PAN study. Thromb Res. 2017 Dec;160:76-82. doi: 10.1016/j.thromres.2017.10.025. Epub 2017 Nov 4.

    PMID: 29127863RESULT

  • Faye E, Drouet L, De Raucourt E, Green A, Bal-Dit-Sollier C, Boudaoud L, Corcos O, Bergmann JF, Joly F, Lloret-Linares C. Absorption and efficacy of acetylsalicylic acid in patients with short bowel syndrome. Ann Pharmacother. 2014 Jun;48(6):705-10. doi: 10.1177/1060028014526700. Epub 2014 Mar 25.

    PMID: 24667978RESULT

  • Thielke J, Martin J, Weber FL, Schroeder TJ, Goretsky S, Hanto DW. Pharmacokinetics of tacrolimus and cyclosporine in short-bowel syndrome. Liver Transpl Surg. 1998 Sep;4(5):432-4. doi: 10.1002/lt.500040502. No abstract available.

    PMID: 9724482RESULT

  • Ueno T, Tanaka A, Hamanaka Y, Suzuki T. Serum drug concentrations after oral administration of paracetamol to patients with surgical resection of the gastrointestinal tract. Br J Clin Pharmacol. 1995 Mar;39(3):330-2. doi: 10.1111/j.1365-2125.1995.tb04457.x.

    PMID: 7619677RESULT

  • Menardi G, Guggenbichler JP. Bioavailability of oral antibiotics in children with short-bowel syndrome. J Pediatr Surg. 1984 Feb;19(1):84-6. doi: 10.1016/s0022-3468(84)80023-8.

    PMID: 6699766RESULT

MeSH Terms

Conditions

Short Bowel SyndromeBacterial Infections

Interventions

AmoxicillinLevofloxacinOfloxacinTrimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesSulfamethoxazoleBenzenesulfonamidesSulfonamidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Niasha MICHOT, MD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niasha MICHOT, MD

CONTACT

+33383155108n.michot@chru-nancy.fr

Elise Pape

CONTACT

e.pape@chru-nancy.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 31, 2022

Study Start

December 9, 2022

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

August 29, 2024

Record last verified: 2024-08

Locations

FR(1)