Trial | NCT01733966  Report issue

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
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    100
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)
Study Started
May 31
2010
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
Sep 17
2018

Drug Amoxicillin-Clavulanic Acid

3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)

Drug Secnidazole, ciprofloxacine

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)

Secnidazol-Ciprofloxacin Experimental

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

Amoxicillin-Clavulanic Acid Active Comparator

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

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
No Results Posted