Evidence map›Paper›PMID 37279523›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

A Retrospective, Observational Study of 12 Cases of Expanded-Access Customized Phage Therapy: Production, Characteristics, and Clinical Outcomes.

Sabrina I Green, Justin R Clark, Haroldo H Santos, Kyle E Weesner, Keiko C Salazar, Saima Aslam, J William Campbell, Sarah B Doernberg, Emily Blodget, Michele I Morris and 8 more

2 registry-linked trialsOpen access · bronzeAbstract readObservational Study
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
20.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT06559618 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase 1B Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

TypeinterventionalSponsorBarbara TrautnerRan2025 to 2028Enrolled30ConditionsBacteriuria, Spinal Cord Injuries, Asymptomatic Bacteriuria, Escherichia ColiArmsPhage Therapy, Placebo
NCT07619924 early_phase1enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Randomized Controlled Study on the Safety and Efficacy of Phage Cocktail in the Treatment of Multidrug-Resistant Bacterial Skin Infections

TypeinterventionalSponsorFirst Affiliated Hospital Xi'an Jiaotong UniversityRan2025 to 2028Enrolled150ConditionsPhage Therapy, Bacteriophage Therapy, Skin and Soft Tissue InfectionsArmsBacteriophage Treatment, Placebo treatment using 0.9% normal saline
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 81 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Article
  6. Phage as a prospective arsenal against superbugs.Molecular biology reports · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Characterization ofPHAGE (New Rochelle, N.Y.) · 2026
    Article
  11. Review
  12. Review
  13. Bacteriophages: A Long-forgotten Past, or Hope for the Future?Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2026
    Article
  14. Discovery and characterization of a novelPHAGE (New Rochelle, N.Y.) · 2026
    Article
  15. Review
  16. Review
  17. Article
  18. Antibiotics (Basel, Switzerland) · 2026
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

Sabrina I GreenTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Justin R ClarkTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Haroldo H SantosTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Kyle E WeesnerTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Keiko C SalazarTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Saima AslamDivision of Infectious Diseases and Global Public Health, Center for Innovative Phage Applications and Therapeutics, University of California, San Diego, La Jolla, California, USA.
J William CampbellDivision of Infectious Diseases and Infection Prevention, St. Luke's Hospital, Chesterfield, Missouri, USA.
Sarah B DoernbergDivision of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
Emily BlodgetDepartment of Medicine, University of California, Irvine, California, USA.
Michele I MorrisDivision of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Gina A SuhDivision of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Karam ObeidDivision of Infectious Diseases and International Medicine, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Fernanda P SilveiraDivision of Infection Diseases, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Andrey A FilippovWound Infections Department, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
Katrine L WhitesonDepartment of Molecular Biology and Biochemistry, University of California, Irvine, California, USA.
Barbara W TrautnerDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.
Austen L TerwilligerTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Anthony MaressoTailored Antibacterials and Innovative Laboratories for Phage (Φ) Research (TAILΦR), Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Baylor College of Medicine · USUniversity of California, Irvine · USMayo Clinic in Florida · USMichael E. DeBakey VA Medical Center · USSt. Luke's Hospital · USUniversity of California San Diego · USUniversity of California, San Francisco · USUniversity of Miami · USUniversity of Minnesota · USUniversity of Pittsburgh Medical Center · USWalter Reed Army Institute of Research · US

Funding

Developing synergistic antibiotic and phage cocktails to target bacterial pathogensR21AI149354 · NIAID · UNIVERSITY OF CALIFORNIA-IRVINE · PI PRIDE, DAVID TEVIS, WHITESON, KATRINE · 2020 to 2021
$427k
Bacteriophage to treat multidrug‐resistant UTI in Persons with Spinal Cord InjuryI01RX002595 · VA · MICHAEL E DEBAKEY VA MEDICAL CENTER · PI TRAUTNER, BARBARA WELLS · 2019 to 2023
–
NIAID NIH HHS R21 AI149354NIH HHS 157981RRD VA I01 RX002595
6 · The paper itself

Abstract

backgroundAntimicrobial resistance (AMR) is undermining modern medicine, a problem compounded by bacterial adaptation to antibiotic pressures. Phages are viruses that infect bacteria. Their diversity and evolvability offer the prospect of their use as a therapeutic solution. Reported are outcomes of customized phage therapy for patients with difficult-to-treat antimicrobial resistant infections.

methodsWe retrospectively assessed 12 cases of customized phage therapy from a phage production center. Phages were screened, purified, sequenced, characterized, and Food and Drug Administration-approved via the IND (investigational new drug) compassionate-care route. Outcomes were assessed as favorable or unfavorable by microbiologic and clinical standards. Infections were device-related or systemic. Other experiences such as time to treatment, antibiotic synergy, and immune responses were recorded.

resultsFifty requests for phage therapy were received. Customized phages were generated for 12 patients. After treatment, 42% (5/12) of cases showed bacterial eradication and 58% (7/12) showed clinical improvement, with two-thirds of all cases (66%) showing favorable responses. No major adverse reactions were observed. Antibiotic-phage synergy in vitro was observed in most cases. Immunological neutralization of phages was reported in 5 cases. Several cases were complicated by secondary infections. Complete characterization of the phages (morphology, genomics, and activity) and their production (methods, sterility, and endotoxin tests) are reported.

conclusionsCustomized phage production and therapy was safe and yielded favorable clinical or microbiological outcomes in two-thirds of cases. A center or pipeline dedicated to tailoring the phages against a patient's specific AMR bacterial infection may be a viable option where standard treatment has failed.

Indexed as

Bacterial InfectionsBacteriophagesPhage TherapyAnti-Bacterial AgentsBacteriaHumansRetrospective StudiesAnti-Bacterial Agentsantibiotic resistancemicrobiologyphagephage therapy

Identifiers

PMID37279523
PMCPMC10573729
OpenAlexW4379600940

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.