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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Diverticular Sigmoïditis

Intervention / Treatment
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* Drug: Secnidazole, ciprofloxacine
* Drug: Amoxicillin-Clavulanic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secnidazol-Ciprofloxacin<br>2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days | Drug: Secnidazole, ciprofloxacine<br>* 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)<br>|
| Active Comparator: Amoxicillin-Clavulanic Acid<br>3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days | Drug: Amoxicillin-Clavulanic Acid<br>* 3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | the cure rate will be evaluated at the second visit (14 days after the inclusion visit) |