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Infectious DiseasesPhase 3MERAKNCT00828971

A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Amoxicilline/clavulanic in people with Infectious Diseases, run by Bayer at 22 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infectious Diseases
What is being tested?
Avelox (Moxifloxacin, BAY12-8039) and Amoxicilline/clavulanic
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
22 sitesItaly
Study dates
Nov 2008to Oct 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Men or women of age >/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires
  • Hospitalization
  • Initial parenteral therapy for at least 48 hours
  • Complicated by at least one of the following criteria:
  • Involvement of deep soft tissues (e.g. fascial, muscle layers)
Show all 23Show fewer
  • Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
  • Association with a significant underlying disease that may complicate response to treatment.
  • Presence of SIRS (Systemic Inflammatory Response Syndrome) defined as two or more of the following signs or symptoms: - temperature > 38.3°C or < 36°C - white blood cell count > 12.000/mmc or < 4.000 or > 10% bands - pulse rate > 90 beats/min - respiratory rate > 20178 - systolic blood pressure </= 90 mmgHg - decreased capillary refill/mottling > 2 seconds - lactate > 2 mmol/L - altered mental status - hyperglycemia > 120 mg/dl or 7.7 mmol/L in the absence of diabetes - protein C (CPR) > 20 mg/L (VR 0-5)3. Duration of infection < 21 days
  • Diagnosis of one of the following skin and skin structure infections:
  • major abscess(es) associates with extensive cellulitis
  • erysipelas and cellulitis
  • infected pressure ulcers(s)
  • wound infections including: post surgical (surgical incision), post traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse
  • Infected ischemic ulcers with at least one of the following conditions: - Diabetes mellitus - Peripheral vascular disease - Conditions pre-disposing to pressure scores such as paraplegia or peripheral neuropathy
  • Presence of at least 3 of the following local signs and symptoms
  • purulent drainage or discharge
  • erythema extended >1 cm from the wound edge
  • fluctuance
  • pain or tenderness to palpation
  • swelling or induration
  • fever defined as body temperature > 37.5°C (axillary), > 38°C (orally), > 38.5°C (tympanically), or > 39°C (rectally). OR Elevated total peripheral white blood cell (WBC) count> 12,000/mm3 OR > 15% immature neutrophils (blends) regardless of total peripheral WBC count
  • C-reactive protein (CRP) >20 mg/L

Who cannot join

  • Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug).
  • The following skin and skin structure infections:
  • Necrotizing fasciitis including Fournier's gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis.
  • Burn wound infections.
  • Secondary infections of a chronic skin disease (eg, atopic dermatitis).
  • Infection of prosthetic materials. Subjects with removal of a prosthetic device involved in an infection should not be included.
  • Infections where a surgical procedure alone is definitive therapy.
  • Subjects with uncomplicated skin and skin structure infections including

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Italy22 sites

  • Study site

    Bagno Di Ripoli, Firenze, 50100

  • Study site

    Bari, 70124

  • Study site

    Bergamo, 24128

  • Study site

    Bologna, 40138

  • Study site

    Brescia, 25123

  • Study site

    Ferrara, 44100

  • Study site

    Florence, 50139

  • Study site

    Foggia, 71100

  • Study site

    Genova, 16132

  • Study site

    Mantua, 46100

  • Study site

    Messina, 98158

  • Study site

    Naples, 80131

  • Study site

    Padova, 35128

  • Study site

    Perugia, 06122

  • Study site

    Reggio Emilia, 42100

  • Study site

    Rimini, 47900

  • Study site

    Roma, 00149

  • Study site

    Roma, 00168

  • Study site

    Torino, 10149

  • Study site

    Udine, 33100

  • Study site

    Varese, 21100

  • Study site

    Verona, 37126

Other trials in Italy

About this study

Official title: A Prospective, Randomized, Open Label, Active Comparator, Multicenter, National Trial to Compare the Efficacy and Safety of Sequential IV/PO Moxifloxacin 400 mg Once Daily Versus IV Amoxicillin/Clavulanate 2,0/0,2 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanate 875/125 mg Every 8 Hours in the Treatment of Adult Subjects With Complicated Skin and Skin Structure Infections

The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.

Being tested
Avelox (Moxifloxacin, BAY12-8039), Amoxicilline/clavulanic
Keywords
Complicated skin and skin structure infections, cSSSI
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avelox (Moxifloxacin, BAY12-8039)Drug

    Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.

  • Amoxicilline/clavulanicDrug

    IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days

Study groups in NCT00828971
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2Active comparatorNot described
Receives: Drug: Amoxicilline/clavulanic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).

    Measured: Test-of-Cure visit [TOC].

Secondary outcomes (4)

  1. Clinical response assessed by the investigator on treatment Day 3-5

    Measured: Day 3-5

  2. Clinical response assessed by the investigator at the end-of-therapy (EOT).

    Measured: At the end-of-therapy (EOT)

  3. Time to switch from oral to IV therapy

    Measured: Day of switch from oral to IV therapy

  4. Bacteriological response (for microbiologically valid population) at the EOT and TOC

    Measured: At the end-of-therapy (EOT), Test-of-Cure visit [TOC].

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionSep 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828971
Sponsor's protocol ID
12670
Other IDs
2007-001491-36
Acronym
MERAK
Status last verified
Dec 2014
First submitted
23 Jan 2009
Last updated
8 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Amoxicilline/clavulanic in people with Infectious Diseases, run by Bayer at 22 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]). (time frame: Test-of-Cure visit [TOC].). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00828971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.

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