Mild to Moderate Uncomplicated Skin and Skin Structure InfectionsPhase 4NCT00234949
A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections
A Phase 4 study testing cefdinir and cephalexin in people with Mild to Moderate Uncomplicated Skin and Skin Structure Infections, run by Abbott.
Trial summary
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mild to Moderate Uncomplicated Skin and Skin Structure Infections
- What is being tested?
- cefdinir and cephalexin
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to not given
- Phase
- Phase 4
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ambulatory male or female subjects > 13 years old.
- A female subject must be non-lactating and at no risk for pregnancy.
- Diagnosis of USSSI with 2 or more of the following local signs and symptoms:
- Pain/tenderness
- Swelling
- Erythema
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- Localized warmth
- Purulent drainage/discharge
- Induration
- Regional lymph node swelling or tenderness
- Extension of redness
- Acceptable USSSI include, but are not limited to:
- Cellulitis
- Erysipelas
- Impetigo
- Simple abscess
- Wound infection
- Furunculosis
- Folliculitis
- A sample for microbiologic culture must be obtained from the primary infection site within 48 hours prior to study drug administration.
Who cannot join
- Medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the Investigator.
- Subject with a complicated skin and skin structure infection as judged by the investigator.
- A chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware).
- A wound secondary to burn injury or acne vulgaris.
- Any infection site that requires:
- intraoperative surgical debridement;
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- excision of infected lesions or body parts.
- Infections that can be treated by surgical incision alone according to the judgment of the Investigator.
- Any other infection that necessitates the use of additional concomitant oral or parenteral antibiotic therapy.
- Known significant renal or hepatic impairment indicated by:
- Serum Creatinine > 2.0 mg/dL (176.8 mol/L)
- SGOT (AST) > 3x the upper limit of the reference range
- SGPT (ALT) > 3x the upper limit of the reference range
- Alkaline Phosphatase > 2x the upper limit of the reference range
- Total Bilirubin > 2x the upper limit of the reference range
- Underlying condition and/or disease that, according to the judgment of the Investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up.
- The Investigator considers the subject an unsuitable candidate for cefdinir or cephalexin administration
About this study
Official title: A Comparative Study of the Safety, Tolerability, and Efficacy of Cefdinir and Cephalexin for the Treatment of Subjects With Mild to Moderate Uncomplicated Skin and Skin Structure Infections
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.
- Being tested
- cefdinir, cephalexin
- Keywords
- Cefdinir, Cephalexin, Skin Infection
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefdinirDrug
cephalexinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Secondary outcomes (3)
Adverse event rates
Bacteriologic cure rates
Patient reported outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Uncomplicated Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 380 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234949
- Sponsor's protocol ID
- M04-699
- Status last verified
- Oct 2007
- First submitted
- 13 Sep 2005
- Last updated
- 25 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Safety, Tolerability, and Efficacy of Cefdinir and Cephalexin for the Treatment of Subjects With Mild to Moderate Uncomplicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00234949
- Acronym / sponsor ID
- M04-699
- Keywords
- Cefdinir, Cephalexin, Skin Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Ambulatory male or female subjects > 13 years old.
- A female subject must be non-lactating and at no risk for pregnancy.
- Diagnosis of USSSI with 2 or more of the following local signs and symptoms:
- Acceptable USSSI include, but are not limited to:
- A sample for microbiologic culture must be obtained from the primary infection site within 48 hours prior to study drug administration.
Key exclusion criteria (17 listed)
- Medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the Investigator.
- Subject with a complicated skin and skin structure infection as judged by the investigator.
- A chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware).
- A wound secondary to burn injury or acne vulgaris.
- Any infection site that requires:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefdinir | Drug | – |
| cephalexin | Drug | – |
Primary outcome
Clinical cure rate
3 secondary outcomes
Adverse event rates
Bacteriologic cure rates
Patient reported outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Information study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefdinir and cephalexin in people with Mild to Moderate Uncomplicated Skin and Skin Structure Infections, run by Abbott.
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 20 inclusion and 17 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 25 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2007.