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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733966

Acronym

DIVA

Enrollment

100

Registered

2012-11-27

Start date

2010-05-31

Completion date

2012-03-31

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticular Sigmoïditis

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)

Interventions

DRUGSecnidazole, 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)

DRUGAmoxicillin-Clavulanic Acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
comparaison of the 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	the cure rate will be evaluated at the second visit (14 days after the inclusion visit)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026