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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quanta Medical
• Collaborator: Laboratoires Iprad-Vegebom
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Clavulanic Acid; Clavulanic Acids; Secnidazole

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