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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Diverticular Sigmoïditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Secnidazol-Ciprofloxacin

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

Group Type EXPERIMENTAL

Secnidazole, ciprofloxacine

Intervention Type DRUG

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)

Amoxicillin-Clavulanic Acid

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

Group Type ACTIVE_COMPARATOR

Amoxicillin-Clavulanic Acid

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Amoxicillin-Clavulanic Acid

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No