Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections (NCT00685698) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
United States, South Africa40 participantsStarted 2008-06
Plain-language summary
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body weight ≥ 40 kg
* Previously known or newly diagnosed diabetes mellitus, including type 1 and type 2 (per the American Diabetes Association guidelines), which is controlled by proper lifestyle (diet, exercise) or treatment with either oral medications or insulin
* Patients' HbA1c ≦ 12% at screening
* Clinically defined diabetic foot infection of mild or moderate severity (PEDIS grade 2-3) as based on the guideline of the Infectious Diseases Society of America. It includes any inframalleolar infection of the soft-tissue, such as paronychia, cellulitis, myositis, abscesses, and tendonitis
* Evidence of necrotic tissue, purulent collections or abscess that may require excision, incision or drainage (based on investigator's judgment, and a surgeon if needed)
* Must be able to provide suitable tissue specimens (preferably obtained by biopsy or tissue curettage, or purulent fluid aspiration, rather than by swabbing) from the infected wound (after appropriate cleansing and debridement) for Gram-staining and bacterial cultures (aerobes and anaerobes)
* A confirmed Gram-positive pathogen infection by Gram-stain. The criterion to determine patient's eligibility for study recruitment is a Gram-stained smear with at least 1 Gram-positive organism seen in at least two high power fields. A solely Gram-positive pathogen infection or a polymicrobial infection including Gram-positive and Gram-negative pathogens are acceptable within the framework of the study
Exclu…
What they're measuring
1
Clinical Success (in ITT Population)
Timeframe: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination