Trial reportPloS one2020
Ototopical drops containing a novel antibacterial synthetic peptide: Safety and efficacy in adults with chronic suppurative otitis media.
Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 28 citations in OpenAlex.
- Reframing Antimicrobial Peptides beyond Direct Antimicrobial Activity toward Host-Directed Functions and Disease-Specific Therapeutic Applications.Journal of microbiology and biotechnology · 2026Review
- Engineering host‑defense peptides enhanced by artificial intelligence and nano delivery systems to overcome biofilms and antimicrobial resistance.Engineering microbiology · 2026Review
- Overcoming LPS-mediated resistance in gram-negative pathogens: a review of LL-37 analogs and computational design strategies.Archives of microbiology · 2026Review
- Host Defense Antimicrobial Peptides (HDPs) as Regulators of Hemostasis and Vascular Biology.Biomolecules · 2026Review
- Otic Drug Delivery Systems: Current and Future Perspectives.Current pharmaceutical design · 2026Review
- Emerging antimicrobial therapies for Gram-negative infections in human clinical use.npj antimicrobials and resistance · 2025Review
- Cathelicidins: Opportunities and Challenges in Skin Therapeutics and Clinical Translation.Antibiotics (Basel, Switzerland) · 2024Review
- ISOM 2023 Research Panel 5: Interventions- Vaccines and prevention, medical and surgical treatment, and impact of COVID-19 pandemic.International journal of pediatric otorhinolaryngology · 2024Review
- Design methods for antimicrobial peptides with improved performance.Zoological research · 2023Review
- Staph wars: the antibiotic pipeline strikes back.Microbiology (Reading, England) · 2023Review
- Are Antimicrobial Peptides a 21st-Century Solution for Atopic Dermatitis?International journal of molecular sciences · 2023Review
- Antimicrobial Peptides in Infectious Diseases and Beyond-A Narrative Review.Life (Basel, Switzerland) · 2023Review
- Novel antimicrobial strategies to treat multi-drug resistant Staphylococcus aureus infections.Microbial biotechnology · 2023Review
- Strategic Approaches to Improvise Peptide Drugs as Next Generation Therapeutics.International journal of peptide research and therapeutics · 2023Review
- Where Electrostatics Matter: Bacterial Surface Neutralization and Membrane Disruption by Antimicrobial Peptides SAAP-148 and OP-145.Biomolecules · 2022Article
- Synergism between the Synthetic Antibacterial and Antibiofilm Peptide (SAAP)-148 and Halicin.Antibiotics (Basel, Switzerland) · 2022Article
- Cathelicidin LL-37 in Health and Diseases of the Oral Cavity.Biomedicines · 2022Review
- Membrane Activity of LL-37 Derived Antimicrobial Peptides againstBiomolecules · 2022Article
- Antimicrobial Peptides: From Design to Clinical Application.Antibiotics (Basel, Switzerland) · 2022Review
- Antibiofilm activity of host defence peptides: complexity provides opportunities.Nature reviews. Microbiology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveChronic suppurative otitis media (CSOM) is a chronic infectious disease with worldwide prevalence that causes hearing loss and decreased quality of life. As current (antibiotic) treatments often unsuccessful and antibiotic resistance is emerging, alternative agents and/or strategies are urgently needed. We considered the synthetic antimicrobial and anti-biofilm peptide P60.4Ac to be an interesting candidate because it also displays anti-inflammatory activities including lipopolysaccharide-neutralizing activity. The aim of the present study was to investigate the safety and efficacy of ototopical drops containing P60.4Ac in adults with CSOM without cholesteatoma.
methodsWe conducted a range-finding study in 16 subjects followed by a randomized, double blinded, placebo-controlled, multicentre phase IIa study in 34 subjects. P60.4Ac-containing ototopical drops or placebo drops were applied twice a day for 2 weeks and adverse events (AEs) and medication use were recorded. Laboratory tests, swabs from the middle ear and throat for bacterial cultures, and audiometry were performed at intervals up to 10 weeks after therapy. Response to treatment was assessed by blinded symptom scoring on otoscopy.
resultsApplication of P60.4Ac-containing ototopical drops (0.25-2.0 mg of peptide/ml) in the ear canal of patients suffering from CSOM was found to be safe and well-tolerated. The optimal dose (0.5 mg of peptide/ml) was selected for the subsequent phase IIa study. Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity. In addition to this excellent safety profile, P60.4Ac ototopical drops resulted in a treatment success in 47% of cases versus 6% in the placebo group.
conclusionThe efficacy/safety balance assessed in the present study provides a compelling justification for continued clinical development of P60.4Ac in therapy-resistant CSOM.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.