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)
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| ClinicalTrials.gov Identifier: NCT01733966 |
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Recruitment Status :
Terminated
(difficulties to recruit patients who suffer from this pathology)
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
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Sponsor:
Quanta Medical
Collaborator:
Laboratoires Iprad-Vegebom
Information provided by (Responsible Party):
Quanta Medical
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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 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Secnidazol-Ciprofloxacin
2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days
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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) |
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Active Comparator: Amoxicillin-Clavulanic Acid
3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days
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Drug: Amoxicillin-Clavulanic Acid
3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days) |
Primary Outcome Measures :
- 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) ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| 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
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| 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 Key Record Dates |
| Last Update Posted: | November 27, 2012 |
| Last Verified: | March 2010 |
Additional relevant MeSH terms:
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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 |