NCT01519492

A Phase 2, Open-Label, Multi-Center Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococci

Completed Phase 2 Last updated 3 August 2012

What this trial tests

Phase 2 trial testing AFN-12520000 in Skin and Subcutaneous Tissue Bacterial Infections in 103 participants. Completed in 1 August 2012.

Timeline

1 February 2012

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Affinium Pharmaceuticals, Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	103
Start date	1 February 2012
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	14 locations across United States, Canada

Drugs / interventions tested

• AFN-12520000 — full drug profile →

Conditions studied

• Skin and Subcutaneous Tissue Bacterial Infections — all drugs for Skin and Subcutaneous Tissue Bacterial Infections →
• Wound Infection — all drugs for Wound Infection →
• Cutaneous Abscess — all drugs for Cutaneous Abscess →
• Burn Infection — all drugs for Burn Infection →

Sponsor

Affinium Pharmaceuticals, Ltd — full company profile →

Who can join

Adults 18 to 70, any sex, with Skin and Subcutaneous Tissue Bacterial Infections or Wound Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety
  Time frame: From time of consent to long term follow-up (max of 42 days)
  To assess the safety, tolerability, and efficacy of AFN-12520000 in patients with staphylococcal ABSSSI by exploring a variety of endpoints of clinical response and the rate and type of adverse events from baseline to the long term follow-up.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancements in Regenerative Strategies Through the Continuum of Burn Care.
   Stone Ii R, Natesan S, Kowalczewski CJ, Mangum LH, et al · · 2018 · cited 73× · PMID 30038569 · DOI 10.3389/fphar.2018.00672
2. Efficacy and Safety of AFN-1252, the First Staphylococcus-Specific Antibacterial Agent, in the Treatment of Acute Bacterial Skin and Skin Structure Infections, Including Those in Patients with Significant Comorbidities.
   Hafkin B, Kaplan N, Murphy B. · · 2015 · cited 44× · PMID 26711777 · DOI 10.1128/aac.01741-15
3. Novel antimicrobial strategies to treat multi-drug resistant Staphylococcus aureus infections.
   Douglas EJA, Wulandari SW, Lovell SD, Laabei M. · · 2023 · cited 40× · PMID 37178319 · DOI 10.1111/1751-7915.14268
4. A Review of Fatty Acid Biosynthesis Enzyme Inhibitors as Promising Antimicrobial Drugs.
   Bibens L, Becker JP, Dassonville-Klimpt A, Sonnet P. · · 2023 · cited 32× · PMID 36986522 · DOI 10.3390/ph16030425
5. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
   Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
6. Staph wars: the antibiotic pipeline strikes back.
   Douglas EJA, Laabei M. · · 2023 · cited 10× · PMID 37656158 · DOI 10.1099/mic.0.001387
7. How to spare gut microbiota from antibiotic effects? PK-PD based innovative strategies, target specificity, and molecule-to-medicinal properties.
   Rai A, Newaskar V, Roy N, Guchhait SK. · · 2025 · PMID 41000251 · DOI 10.1039/d5md00591d