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Soft Tissue InfectionsPhase 2NCT00303589

A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

A Phase 2 study testing beta-lactam in people with Soft Tissue Infections, run by Hoffmann-La Roche at 62 sites in 11 countries.

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

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Infections
What is being tested?
beta-lactam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
62 sitesin 11 countries
Study dates
Dec 2005to Oct 2007
Phase
Phase 2
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

  • adult patients, >=18 years of age;
  • skin or skin structure infection requiring hospitalization;
  • clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment;
  • material from site of infection is clinically purulent or seropurulent.

Who cannot join

  • presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation);
  • known or suspected concomitant bacterial infection requiring antibiotic treatment;
  • skin infection or chronic non-healing ulcer of > 2 weeks duration;
  • patients in whom surgery is the primary treatment.

Trial locations and contacts

62 sites in 11 countries.

62 sites in 11 countries

Argentina15 sites

  • Study site

    Buenos Aires, 1282

  • Study site

    Buenos Aires, 1430

  • Study site

    Buenos Aires, 1657

  • Study site

    Buenos Aires, 1888

  • Study site

    Ciudadela, 1702

  • Study site

    Córdoba, 5000

  • Study site

    Córdoba, X5004CDT

  • Study site

    El Palomar, 1684

  • Study site

    Entre Ríos, 3100

  • Study site

    Granadero Baigorria, 2152

  • Study site

    Merlo, 1722

  • Study site

    Neuquén, 8300

  • Study site

    Rosario, 2000

  • Study site

    Rosario, S2000DSV

  • Study site

    Santa Fe, 3000

Other trials in Argentina

United States8 sites

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Miami Beach, Florida, 33139

  • Study site

    Minneapolis, Minnesota, 55422

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

South Africa7 sites

  • Study site

    Benoni, 1501

  • Study site

    Cape Town, 7530

  • Study site

    Middleburg, 1050

  • Study site

    Port Elizabeth, 6020

  • Study site

    Pretoria, 0082

  • Study site

    Sommerset West, 7130

  • Study site

    Themba, 0040

Other trials in South Africa

Lithuania5 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

  • Study site

    Vilnius, 04130

  • Study site

    Vilnius, 08661

  • Study site

    Vilnius, 10207

Other trials in Lithuania

Romania5 sites

  • Study site

    Bucharest, 014461

  • Study site

    Bucharest, 041914

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Constanța, 900591

  • Study site

    Târgu Mureş, 540342

Other trials in Romania

Bulgaria4 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1606

  • Study site

    Varna, 9000

Other trials in Bulgaria

Germany4 sites

  • Study site

    Lübeck, 23538

  • Study site

    Mainz, 55131

  • Study site

    München, 81377

  • Study site

    Münster, 48157

Other trials in Germany

Latvia4 sites

  • Study site

    Liepāja, 3402

  • Study site

    Riga, 1001

  • Study site

    Riga, 1002

  • Study site

    Riga, 1038

Other trials in Latvia

Peru4 sites

  • Study site

    La Victoria, Lima, Lima 13

  • Study site

    Lima, 11

  • Study site

    Lima, 1

  • Study site

    Lima

Other trials in Peru

Estonia3 sites

  • Study site

    Tallinn, 11312

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 51014

Other trials in Estonia

Hungary3 sites

  • Study site

    Budapest, 1076

  • Study site

    Budapest, H-1082

  • Study site

    Győr, 9024

Other trials in Hungary

About this study

Official title: A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

Being tested
Standard care, beta-lactam
Medical subject headings
Soft Tissue Infections

What participants receive

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

  • Standard careDrug

    As prescribed

  • beta-lactamDrug

    750mg iv q8h

  • beta-lactamDrug

    1500mg iv q8h

Study groups in NCT00303589
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: beta-lactam
2ExperimentalNot described
Receives: Drug: beta-lactam
3Active comparatorNot described
Receives: Drug: Standard care

What is being measured

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

  1. Clinical cure rate.

    Measured: Event driven

Secondary outcomes (4)

  1. Time to clinical cure

    Measured: Event driven

  2. Time to resolution of signs and symptoms of skin or soft tissue infection

    Measured: Event driven

  3. Bacteriological outcome

    Measured: Event driven

  4. Adverse events; laboratory abnormalities

    Measured: Throughout study

Timeline

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

  1. First posted17 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionOct 2007
  4. Study completionOct 2007

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303589
Sponsor's protocol ID
WI18274
Status last verified
Nov 2016
First submitted
16 Mar 2006
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing beta-lactam in people with Soft Tissue Infections, run by Hoffmann-La Roche at 62 sites in 11 countries.

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 4 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Argentina, United States, South Africa, Lithuania, Romania and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 cure rate. (time frame: Event driven). 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 NCT00303589.

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 2 Nov 2016.

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