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A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults (DIVA)

Primary Purpose

Diverticular Sigmoïditis

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Secnidazole, ciprofloxacine
Amoxicillin-Clavulanic Acid
Sponsored by
Quanta Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticular Sigmoïditis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult
  • Recovering of written and dated informed consent form
  • Social Security medical cover
  • Left Iliac Fossa (LIF) pain
  • Moderate fever (>37.8°C)
  • Sensitivity/defence during LIF palpation

Biological results :

  • CRP > 10mg/L
  • NFS > 10G/L
  • Neutrophil Granulocytosis > 75%
  • Radiological results - presence to the scan :diverticul & pericolic infiltration

Exclusion Criteria:

  • Patients treated by antibiotherapy in the last 15 days prior inclusion
  • Patients treated by morphinic drug
  • Patients treated by anticoagulant drug
  • Pregnant or breast-feeding women
  • Patients presenting allergy to active principal, to galactose
  • Patients having taking part in another study in the last 3 months prior inclusion
  • Patients unable to comply with the study requirements
  • Patients presenting Chronic affection inconsistent with the study
  • Patients presenting high fever
  • Patients presenting abdominal contracture
  • Patients presenting immunosuppression
  • Radiological sign of complication (abscess>3cm)
  • Patients presenting Pathology inconsistent with efficacy evaluatio

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Secnidazol-Ciprofloxacin

    Amoxicillin-Clavulanic Acid

    Arm Description

    2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days

    3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days

    Outcomes

    Primary Outcome Measures

    comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2012
    Last Updated
    September 13, 2018
    Sponsor
    Quanta Medical
    Collaborators
    Laboratoires Iprad-Vegebom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01733966
    Brief Title
    A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
    Acronym
    DIVA
    Official Title
    A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    difficulties to recruit patients who suffer from this pathology
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Quanta Medical
    Collaborators
    Laboratoires Iprad-Vegebom

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure. The cure rate will be evaluated at the second visit (14 days after the inclusion visit)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diverticular Sigmoïditis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Secnidazol-Ciprofloxacin
    Arm Type
    Experimental
    Arm Description
    2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days
    Arm Title
    Amoxicillin-Clavulanic Acid
    Arm Type
    Active Comparator
    Arm Description
    3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    Secnidazole, ciprofloxacine
    Intervention Description
    2g of microgranules of secnidazole. a single dose per day during 3 days. 1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin-Clavulanic Acid
    Intervention Description
    3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)
    Primary Outcome Measure Information:
    Title
    comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
    Time Frame
    the cure rate will be evaluated at the second visit (14 days after the inclusion visit)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult Recovering of written and dated informed consent form Social Security medical cover Left Iliac Fossa (LIF) pain Moderate fever (>37.8°C) Sensitivity/defence during LIF palpation Biological results : CRP > 10mg/L NFS > 10G/L Neutrophil Granulocytosis > 75% Radiological results - presence to the scan :diverticul & pericolic infiltration Exclusion Criteria: Patients treated by antibiotherapy in the last 15 days prior inclusion Patients treated by morphinic drug Patients treated by anticoagulant drug Pregnant or breast-feeding women Patients presenting allergy to active principal, to galactose Patients having taking part in another study in the last 3 months prior inclusion Patients unable to comply with the study requirements Patients presenting Chronic affection inconsistent with the study Patients presenting high fever Patients presenting abdominal contracture Patients presenting immunosuppression Radiological sign of complication (abscess>3cm) Patients presenting Pathology inconsistent with efficacy evaluatio

    12. IPD Sharing Statement

    Learn more about this trial

    A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults

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