A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial… (NCT01519492) | Clinical Trial Compass
CompletedPhase 2
A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci
United States103 participantsStarted 2012-02
Plain-language summary
The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent and to understand the demands of the protocol;
* Ages of 18 and 70 years, inclusive;
* Have clinically documented ABSSSI suspected or documented to be caused by staphylococci accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2 and can be categorized as one or more of the following: Wound infection; Cutaneous abscess Burn infection (≤20% of total body surface area) or Cellulitis
* Have a primary infected lesion with at least three of the following: Significant pain or tenderness to palpation; Purulent or seropurulent drainage or discharge; Erythema; Fluctuance; Induration; Edema; Heat or localized warmth;
* Have at least two of the following signs and symptoms of systemic inflammation or complicating factors: Documented or reported fever \>38.0°C; WBC count of \>10,000 cells/mm3; Greater than 15% immature neutrophils irrespective of total WBC; Elevated CRP or ESR; or Local/regional lymphadenopathy;
* Have a Gram stain with Gram-positive cocci in clusters or PCR result indicating an infection with Staphylococci.
* Have clearly failed as defined in the protocol previous treatment after a minimum of 48 hours
* Women of childbearing potential must have a negative pregnancy test at screening before enrollment
* Male and Female patients must utilize a highly effective method of contraception
* In the judgment of the Investigator have an expectation of survival and prompt improvement with effecti…
What they're measuring
1
Safety
Timeframe: From time of consent to long term follow-up (max of 42 days)