Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-12

Study Completion Date

2017-05-02

Brief Summary

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This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

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Detailed Description

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Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Conditions

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Clostridium Difficile Infection

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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Cadazolid

Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days

Group Type EXPERIMENTAL

Cadazolid

Intervention Type DRUG

Cadazolid 250 mg as oral suspension twice daily.

Vancomycin-matching placebo

Intervention Type DRUG

Placebo capsules matching vancomycin and administered orally 4 times per day

Vancomycin

Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin 125 mg as oral capsules 4 times daily

Cadazolid-matching placebo

Intervention Type DRUG

Placebo matching cadazolid and administered orally twice daily

Interventions

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Cadazolid

Cadazolid 250 mg as oral suspension twice daily.

Intervention Type DRUG

Vancomycin

Vancomycin 125 mg as oral capsules 4 times daily

Intervention Type DRUG

Cadazolid-matching placebo

Placebo matching cadazolid and administered orally twice daily

Intervention Type DRUG

Vancomycin-matching placebo

Placebo capsules matching vancomycin and administered orally 4 times per day

Intervention Type DRUG

Other Intervention Names

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ACT-179811 Vancocin

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent.
* Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
* Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.

Exclusion Criteria

* More than one previous episode of CDAD in the 3-month period prior to randomization.
* Evidence of life-threatening or fulminant CDAD.
* Likelihood of death within 72 hours from any cause.
* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
* Antimicrobial treatment active against CDAD administered for \> 24 hours except for metronidazole treatment failures (MTF)
* Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
* Unable or unwilling to comply with all protocol requirements.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No