Health TrialsbyHealthPanel

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

ConditionsShort Bowel SyndromeInfection, Bacterial
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 4 treatment groups
Group A: AmoxicillinExperimental treatment 1 intervention
Group B: OfloxacinExperimental treatment 1 intervention
Group C: LevofloxacinExperimental treatment 1 intervention
Group D: Sulfamethoxazole trimethoprimExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Time -0.5 hours
2

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

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

Time frame
Time +0.5 hours
3

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

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

Time frame
Time +1 hour
4

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

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

Time frame
Time +1.5 hour

Secondary outcomes

1

Describe antibiotic absorption after oral administration in these patients

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
2

Describe antibiotic absorption after oral administration in these patients

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
3

Describe antibiotic absorption after oral administration in these patients

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
4

Assess link between length of remaining bowel and antibiotic absorption

Length of remaining bowel (cm)

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Société Francophone Nutrition Clinique et Métabolisme

Collaborator

FIlière des Maladies rares Abdomino-THOraciques

Collaborator

Fresenius Kabi

Collaborator

Source ClinicalTrials.gov
Apply now