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Benzathine Benzylpenicillin

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Oriol Mitja – 1st expert on this subject based on the ideXlab platform

  • New Treatment Schemes for Yaws: The Path Toward Eradication
    Clinical Infectious Diseases, 2012
    Co-Authors: Oriol Mitja, Russell Hays, Andrea C. Rinaldi, Robyn Mcdermot, Quique Bassat

    Abstract:

    Yaws—an infectious disease caused by Treponemapallidum subsp. pertenue—is a paradigmatic example ofthe neglected tropical disease and is reemerging as apublic health concern in many countries, causing suf-fering particularly in children aged 500000 people,mostly children in poor rural areas, were affected bythe disease [4]. Some of the most important endemicfoci today are located in Africa (Ghana, Congo, Cam-eroon) [5], Southeast Asia (Indonesia, Timor-Leste),and the Pacific islands (Papua New Guinea, SolomonIslands, Vanuatu) [6], but figures for the number ofpeople infected are imprecise due to patchy surveying,especially in isolated districts and islands [7].STANDARD ANTIBIOTIC TREATMENTThe WHO yaws treatment guidelines date to the1950s, and since then, no alternatives to penicillin forfirst-line treatment have been introduced. Penicillinwas proven to be highly effective against yaws andother treponemal diseases in 1948, and it revolution-ized the therapy of these infections. Tests on experi-mentally infected animals and infected patientsshowed that Benzylpenicillin levels >0.03 units/mL ofserum maintained for at least 7 days were treponemi-cidal [8]. These levels can be achieved either by givingrepeated doses of short-acting Benzylpenicillin prepa-rations (ie, aqueous Benzylpenicillin) or a single intra-muscular injection of slowly absorbed, repositoryBenzylpenicillin preparations such as Benzathine ben-zylpenicillin or penicillin aluminium monostearate [9].Intramuscular Benzathine Benzylpenicillin was chosenas the preferred treatment for yaws because of itsconvenient pharmacokinetics and manufacturingadvantages. The WHO guidelines still recommend 1intramuscular injection of long-acting Benzathine ben-zylpenicillin at a dose of 1.2 MU for adults and 0.6MU for children [7].

  • single dose azithromycin versus Benzathine Benzylpenicillin for treatment of yaws in children in papua new guinea an open label non inferiority randomised trial
    The Lancet, 2012
    Co-Authors: Oriol Mitja, Russell Hays, Anthony Ipai, Moses Penias, Raymond Paru, David Fagaho, Elisa De Lazzari, Quique Bassat

    Abstract:

    Summary Background Yaws—an endemic treponematosis and, as such, a neglected tropical disease—is re-emerging in children in rural, tropical areas. Oral azithromycin is effective for syphilis. We assessed the efficacy of azithromycin compared with intramuscular long-acting penicillin to treat patients with yaws. Methods We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50 000 units per kg Benzathine Benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004. Findings We allocated 124 patients to the azithromycin group and 126 to the Benzathine Benzylpenicillin group. In the per-protocol analysis, after 6 months of follow-up, 106 (96%) of 110 patients in the azithromycin group were cured, compared with 105 (93%) of 113 in the Benzathine Benzylpenicillin group (treatment difference −3·4%; 95% CI −9·3 to 2·4), thus meeting prespecified criteria for non-inferiority. The number of drug-related adverse events (all mild or moderate) was similar in both treatment groups (ten [8%] in the azithromycin group vs eight [7%] in the Benzathine Benzylpenicillin group). Interpretation A single oral dose of azithromycin is non-inferior to Benzathine Benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programmes. Funding International SOS and Newcrest Mining.

Asha C Bowen – 2nd expert on this subject based on the ideXlab platform

  • a population pharmacokinetic study of Benzathine Benzylpenicillin g administration in children and adolescents with rheumatic heart disease new insights for improved secondary prophylaxis strategies
    Journal of Antimicrobial Chemotherapy, 2019
    Co-Authors: Robert Hand, Asha C Bowen, Sam Salman, Nelly Newall, Julie Vine, Madhu Pagesharp, Katherine Gray, Amy Baker, Joseph Kado

    Abstract:

    Background
    Benzathine Benzylpenicillin G (BPG) is recommended as secondary prophylaxis to prevent recurrence of acute rheumatic fever and subsequent rheumatic heart disease (RHD). Following intramuscular injection, BPG is hydrolysed to Benzylpenicillin. Little is known of the pharmacokinetics of Benzylpenicillin following BPG in populations at risk of RHD.

  • The importance of scabies coinfection in the treatment considerations for impetigo
    Pediatric Infectious Disease Journal, 2016
    Co-Authors: Tasani M, Steven Y C Tong, Ross M Andrews, Bart J Currie, Deborah C. Holt, Carapetis, Asha C Bowen

    Abstract:

    Skin infections account for a high disease burden in indigenous children living in northern Australia. Although the relationship between impetigo and scabies is recognized, the prevalence of scabies in children with impetigo is not well reported. We report the prevalence, demographics and treatment success outcomes of impetigo and scabies coinfection in indigenous children who were participants in a randomized controlled trial of impetigo treatment conducted in remote communities of the Northern Territory, Australia.Of 1715 screening episodes for impetigo, 508 children were randomized to receive intramuscular Benzathine Benzylpenicillin (BPG), twice daily co-trimoxazole (SXT) for 3 days (4 mg/kg trimethoprim plus 20 mg/kg sulfamethoxazole per dose) or once daily SXT for 5 days (8 mg/kg trimethoprim plus 40 mg/kg sulfamethoxazole per dose). A clinical diagnosis of scabies; tinea of the skin, scalp or nail; and head lice was made on all children. Scabies presence was not confirmed using diagnostic scrapings. In a post-hoc analysis, we determined whether coinfection with scabies had an impact on treatment success for impetigo.Of children randomized to receive treatment for impetigo, 84 of 508 (16.5%) had scabies. The presence of scabies ranged from 14.3% to 20.0% in the 3 treatment groups. Treatment success for impetigo with and without scabies coinfection, independent of the treatment groups, was 75.9% and 86.6%, respectively, absolute difference 10.7% [95% confidence interval (CI): +1% to +21%]. Treatment success for impetigo with and without scabies coinfection in the BPG group was 69.6% and 88.0%, respectively, absolute difference 18.4% (95% CI: -1% to +38%). In the pooled SXT groups, the treatment success for impetigo with and without scabies coinfection was 78.6% and 86.0%, respectively, with absolute difference 7.4% (95% CI: -4% to +18%). Treatment success in the pooled SXT group with scabies (78.6%) was higher than in the BPG group (69.6%) with scabies, absolute difference 9.0% (95% CI: +0.1% to +18%). Prediction of treatment success for impetigo is dependent on the presence or absence of scabies and for scabies coinfected impetigo it was higher in the group treated with SXT.The burden of scabies in an impetigo trial for Indigenous children was high. Treatment success for scabies coinfection was lower than for impetigo overall, with a higher success seen in the SXT group than the BPG group.

  • short course oral co trimoxazole versus intramuscular Benzathine Benzylpenicillin for impetigo in a highly endemic region an open label randomised controlled non inferiority trial
    The Lancet, 2014
    Co-Authors: Asha C Bowen, Steven Y C Tong, Ross M Andrews, Irene M Omeara, Malcolm Mcdonald, Mark D Chatfield, Bart J Currie, Jonathan R Carapetis

    Abstract:

    Summary Background Impetigo affects more than 110 million children worldwide at any one time. The major burden of disease is in developing and tropical settings where topical antibiotics are impractical and lead to rapid emergence of antimicrobial resistance. Few trials of systemic antibiotics are available to guide management of extensive impetigo. As such, we aimed to compare short-course oral co-trimoxazole with standard treatment with intramuscular Benzathine Benzylpenicillin in children with impetigo in a highly endemic setting. Methods In this randomised, controlled, non-inferiority trial, Indigenous Australian children aged 3 months to 13 years with purulent or crusted non-bullous impetigo were randomly assigned (1:1:1) to receive Benzathine Benzylpenicillin (weight-banded injection), twice-daily co-trimoxazole for 3 days (4 mg/kg plus 20 mg/kg per dose), or once-daily co-trimoxazole for 5 days (8 mg/kg plus 40 mg/kg per dose). At every visit, participants were randomised in blocks of six and 12, stratified by disease severity. Randomisation was done by research nurses and codes were in sealed, sequentially numbered, opaque envelopes. Independent reviewers masked to treatment allocation compared digital images of sores from days 0 and 7. The primary outcome was treatment success at day 7 in a modified intention-to-treat analysis. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000858291. Findings Between Nov 26, 2009, and Nov 20, 2012, 508 patients were randomly assigned to receive Benzathine Benzylpenicillin (n=165 [156 analysed]), twice-daily co-trimoxazole for 3 days (n=175 [173 analysed]), or once-daily co-trimoxazole for 5 days (n=168 [161 analysed]). Treatment was successful in 133 (85%) children who received Benzathine Benzylpenicillin and 283 (85%) who received pooled co-trimoxazole (absolute difference 0·5%; 95% CI −6·2 to 7·3), showing non-inferiority of co-trimoxazole (10% margin). Results for twice-daily co-trimoxazole for 3 days and once-daily co-trimoxazole for 5 days were similar. Adverse events occurred in 54 participants, 49 (90%) of whom received Benzathine Benzylpenicillin. Interpretation Short-course co-trimoxazole is a non-inferior, alternative treatment to Benzathine Benzylpenicillin for impetigo; it is palatable, pain-free, practical, and easily administered. Funding Australian National Health and Medical Research Council.

Quique Bassat – 3rd expert on this subject based on the ideXlab platform

  • New Treatment Schemes for Yaws: The Path Toward Eradication
    Clinical Infectious Diseases, 2012
    Co-Authors: Oriol Mitja, Russell Hays, Andrea C. Rinaldi, Robyn Mcdermot, Quique Bassat

    Abstract:

    Yaws—an infectious disease caused by Treponemapallidum subsp. pertenue—is a paradigmatic example ofthe neglected tropical disease and is reemerging as apublic health concern in many countries, causing suf-fering particularly in children aged 500000 people,mostly children in poor rural areas, were affected bythe disease [4]. Some of the most important endemicfoci today are located in Africa (Ghana, Congo, Cam-eroon) [5], Southeast Asia (Indonesia, Timor-Leste),and the Pacific islands (Papua New Guinea, SolomonIslands, Vanuatu) [6], but figures for the number ofpeople infected are imprecise due to patchy surveying,especially in isolated districts and islands [7].STANDARD ANTIBIOTIC TREATMENTThe WHO yaws treatment guidelines date to the1950s, and since then, no alternatives to penicillin forfirst-line treatment have been introduced. Penicillinwas proven to be highly effective against yaws andother treponemal diseases in 1948, and it revolution-ized the therapy of these infections. Tests on experi-mentally infected animals and infected patientsshowed that Benzylpenicillin levels >0.03 units/mL ofserum maintained for at least 7 days were treponemi-cidal [8]. These levels can be achieved either by givingrepeated doses of short-acting Benzylpenicillin prepa-rations (ie, aqueous Benzylpenicillin) or a single intra-muscular injection of slowly absorbed, repositoryBenzylpenicillin preparations such as Benzathine ben-zylpenicillin or penicillin aluminium monostearate [9].Intramuscular Benzathine Benzylpenicillin was chosenas the preferred treatment for yaws because of itsconvenient pharmacokinetics and manufacturingadvantages. The WHO guidelines still recommend 1intramuscular injection of long-acting Benzathine ben-zylpenicillin at a dose of 1.2 MU for adults and 0.6MU for children [7].

  • single dose azithromycin versus Benzathine Benzylpenicillin for treatment of yaws in children in papua new guinea an open label non inferiority randomised trial
    The Lancet, 2012
    Co-Authors: Oriol Mitja, Russell Hays, Anthony Ipai, Moses Penias, Raymond Paru, David Fagaho, Elisa De Lazzari, Quique Bassat

    Abstract:

    Summary Background Yaws—an endemic treponematosis and, as such, a neglected tropical disease—is re-emerging in children in rural, tropical areas. Oral azithromycin is effective for syphilis. We assessed the efficacy of azithromycin compared with intramuscular long-acting penicillin to treat patients with yaws. Methods We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50 000 units per kg Benzathine Benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004. Findings We allocated 124 patients to the azithromycin group and 126 to the Benzathine Benzylpenicillin group. In the per-protocol analysis, after 6 months of follow-up, 106 (96%) of 110 patients in the azithromycin group were cured, compared with 105 (93%) of 113 in the Benzathine Benzylpenicillin group (treatment difference −3·4%; 95% CI −9·3 to 2·4), thus meeting prespecified criteria for non-inferiority. The number of drug-related adverse events (all mild or moderate) was similar in both treatment groups (ten [8%] in the azithromycin group vs eight [7%] in the Benzathine Benzylpenicillin group). Interpretation A single oral dose of azithromycin is non-inferior to Benzathine Benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programmes. Funding International SOS and Newcrest Mining.