A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Potential Efficacy of BACTELIDE vs. Placebo in Addition to Standard-of-care Therapy for S. Aureus, P. Aeruginosa, and K. Pneumoniae Colonized Pressure Injuries

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

开始日期2022-01-01

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菲吉乐科股份有限公司

100 项与 Bacteriophage therapy(Phagelux) 相关的临床结果

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100 项与 Bacteriophage therapy(Phagelux) 相关的转化医学

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100 项与 Bacteriophage therapy(Phagelux) 相关的专利（医药）

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项与 Bacteriophage therapy(Phagelux) 相关的文献（医药）

2023-09-01·The Pediatric infectious disease journal

Bacteriophage Therapy of Multidrug-resistant Achromobacter in an 11-Year-old Boy With Cystic Fibrosis Assessed by Metagenome Analysis.

Article

作者: Hajama, Hamza ; Bradley, John S ; Akong, Kathryn ; Jordan, Mary ; Conrad, Douglas J ; Segall, Anca M ; Stout, Dayna ; Rowe, Ryan S ; Hingtgen, Sara

BACKGROUNDCystic fibrosis (CF) is a genetic disease associated with lung disease characterized by chronic pulmonary infection, increasingly caused by multiple drug-resistant pathogens after repeated antibiotic exposure, limiting antibiotic treatment options. Bacteriophages can provide a pathogen-specific bactericidal treatment used with antibiotics to improve microbiologic and clinical outcomes in CF.METHODSAchromobacter species isolates from sputum of a chronically infected person with CF, were assessed for susceptibility to bacteriophages: 2 highly active, purified bacteriophages were administered intravenously every 8 hours, in conjunction with a 14-day piperacillin/tazobactam course for CF exacerbation. Sputum and blood were collected for metagenome analysis during treatment, with sputum analysis at 1-month follow-up. Assessments of clinical status, pulmonary status and laboratory evaluation for safety were conducted.RESULTSBacteriophage administration was well-tolerated, with no associated clinical or laboratory adverse events. Metagenome analysis documented an 86% decrease in the relative proportion of Achromobacter DNA sequence reads in sputum and a 92% decrease in blood, compared with other bacterial DNA reads, comparing pretreatment and posttreatment samples. Bacteriophage DNA reads were detected in sputum after intravenous administration during treatment, and at 1-month follow-up. Reversal of antibiotic resistance to multiple antibiotics occurred in some isolates during treatment. Stabilization of lung function was documented at 1-month follow-up.CONCLUSIONSBacteriophage/antibiotic treatment decreased the host pulmonary bacterial burden for Achromobacter assessed by metagenome analysis of sputum and blood, with ongoing bacteriophage replication documented in sputum at 1-month follow-up. Prospective controlled studies are needed to define the dose, route of administration and duration of bacteriophage therapy for both acute and chronic infection in CF.

2023-01-01·Frontiers in medicine

Combining bacteriophage and vancomycin is efficacious against MRSA biofilm-like aggregates formed in synovial fluid.

Article

作者: Lightly, Tasia J ; Abdelbary, Hesham ; Peters, Danielle ; Theriault, Steven S ; Chen, Wangxue ; Arnaud, Tia ; Cook, Bradley W M ; Taha, Mariam ; Wang, Liyuan

BackgroundBiofilm formation is a major clinical challenge contributing to treatment failure of periprosthetic joint infection (PJI). Lytic bacteriophages (phages) can target biofilm associated bacteria at localized sites of infection. The aim of this study is to investigate whether combination therapy of phage and vancomycin is capable of clearing Staphylococcus aureus biofilm-like aggregates formed in human synovial fluid.MethodsIn this study, S. aureus BP043, a PJI clinical isolate was utilized. This strain is a methicillin-resistant S. aureus (MRSA) biofilm-former. Phage Remus, known to infect S. aureus, was selected for the treatment protocol. BP043 was grown as aggregates in human synovial fluid. The characterization of S. aureus aggregates was assessed for structure and size using scanning electron microscopy (SEM) and flow cytometry, respectively. Moreover, the formed aggregates were subsequently treated in vitro with: (a) phage Remus [∼10⁸ plaque-forming units (PFU)/ml], (b) vancomycin (500 μg/ml), or (c) phage Remus (∼10⁸ PFU/ml) followed by vancomycin (500 μg/ml), for 48 h. Bacterial survival was quantified by enumeration [colony-forming units (CFU)/ml]. The efficacy of phage and vancomycin against BP043 aggregates was assessed in vivo as individual treatments and in combination. The in vivo model utilized Galleria mellonella larvae which were infected with BP043 aggregates pre-formed in synovial fluid.ResultsScanning electron microscopy (SEM) images and flow cytometry data demonstrated the ability of human synovial fluid to promote formation of S. aureus aggregates. Treatment with Remus resulted in significant reduction in viable S. aureus residing within the synovial fluid aggregates compared to the aggregates that did not receive Remus (p < 0.0001). Remus was more efficient in eliminating viable bacteria within the aggregates compared to vancomycin (p < 0.0001). Combination treatment of Remus followed by vancomycin was more efficacious in reducing bacterial load compared to using either Remus or vancomycin alone (p = 0.0023, p < 0.0001, respectively). When tested in vivo, this combination treatment also resulted in the highest survival rate (37%) 96 h post-treatment, compared to untreated larvae (3%; p < 0.0001).ConclusionWe demonstrate that combining phage Remus and vancomycin led to synergistic interaction against MRSA biofilm-like aggregates in vitro and in vivo.

2012-04-01·Livestock Science3区 · 农林科学

Evaluation of oral administration of bacteriophages to neonatal calves: Phage survival and impact on fecal Escherichia coli

3区 · 农林科学

Article

作者: Nydam, D V ; Santos, T M A ; Bicalho, M L S ; Bicalho, R C ; Machado, V S

Diarrhea is an important cause of morbidity and mortality in neonatal calves. Several enteropathogens are associated with diarrhea in young calves, with Enterotoxigenic Escherichia coli (ETEC) infection being the most common type of colibacillosis. The rise of antibiotic resistance in a number of medically important bacterial pathogens has revived interest in the use of bacteriophages as anti-bacterial therapeutic agents. Here we describe the results of a randomized, placebo-controlled, double-blinded study designed to evaluate the effect of an oral bacteriophage cocktail on fecal E. coli colony-forming units (CFU). Ten calves were enrolled in the study to either the bacteriophage group or the placebo group for 22 feedings. Calves in the bacteriophage treatment group (n = 6) received a total of 10⁶ plaque-forming units (PFU) (volume = 5 ml) of each of four bacteriophages while the placebo group (n = 4) received only phosphate-buffered saline (5 ml). Fresh fecal samples and blood samples were collected daily from each calf and analyzed for bacterial count and presence of bacteriophage. E. coli-infecting phages were recovered from all phage-treated calves at concentrations of 10² to 10³ PFU per gram of rectal contents, but none was detected in serum. Phage treatment caused a reduction in fecal E. coli when compared to the control group: the mean log CFU for the placebo-treated group was 9.25 (SE = 0.42) versus 9.11 (SE = 0.34) for the phage-treated group, but the difference was not statistically significant.

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