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)

Quanta Medical

Status and phase: Terminated; Phase 3

Conditions: Diverticular Sigmoïditis

Treatments: Drug: Amoxicillin-Clavulanic Acid; Drug: Secnidazole, ciprofloxacine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733966

IPR_SIGMO_09

Details and patient eligibility

About

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)

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Secnidazol-Ciprofloxacin

Experimental group

Description:

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

Treatment:

Drug: Secnidazole, ciprofloxacine

Amoxicillin-Clavulanic Acid

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin-Clavulanic Acid