Suspended

DIVAA 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

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What is being tested

Secnidazole, ciprofloxacine

+ Amoxicillin-Clavulanic Acid

Drug
Who is being recruted

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorQuanta Medical
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

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 TitleA 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
NCT01733966NCT01136434
Principal SponsorQuanta Medical
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers