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)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Condition or disease	Intervention/treatment	Phase
Diverticular Sigmoïditis	Drug: Secnidazole, ciprofloxacine; Drug: Amoxicillin-Clavulanic Acid	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	May 2010
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Secnidazol-Ciprofloxacin; 2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 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)
Active Comparator: Amoxicillin-Clavulanic Acid; 3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days	Drug: Amoxicillin-Clavulanic Acid; 3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)

Outcome Measures

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Primary Outcome Measures :

1. to compare 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) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Quanta Medical
ClinicalTrials.gov Identifier:	NCT01733966 History of Changes
Obsolete Identifiers:	NCT01136434
Other Study ID Numbers:	IPR_SIGMO_09
First Posted:	November 27, 2012
Last Update Posted:	November 27, 2012
Last Verified:	March 2010

Additional relevant MeSH terms:

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Amoxicillin; Ciprofloxacin; Clavulanic Acids; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination; Secnidazole	Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; beta-Lactamase Inhibitors; Antiprotozoal Agents; Antiparasitic Agents