The Experts below are selected from a list of 117 Experts worldwide ranked by ideXlab platform
Anita K M Zaidi - One of the best experts on this subject based on the ideXlab platform.
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simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in pakistan simplified antibiotic therapy trial satt a randomised open label equivalence trial
The Lancet Global Health, 2017Co-Authors: Fatima Mir, Imran Nisar, Shiyam Sundar Tikmani, Benazir Baloch, Sadia Shakoor, Fyezah Jehan, Imran Ahmed, Simon Cousens, Anita K M ZaidiAbstract:Summary Background Parenteral antibiotic therapy for young infants (aged 0–59 days) with suspected sepsis is sometimes not available or feasible in countries with high neonatal mortality. Outpatient treatment could save lives in such settings. We aimed to assess the equivalence of two simplified antibiotic regimens, comprising fewer injections and oral rather than parenteral administration, compared with a reference treatment for young infants with clinical severe infection. Methods We undertook the Simplified Antibiotic Therapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in five communities in Karachi, Pakistan. We enrolled young infants (aged 0–59 days) who either presented at a primary health-care clinic or were identified by a community health worker with signs of clinical severe infection. We included infants who were not critically ill and whose family refused admission. We randomly assigned infants to either intramuscular Procaine Benzylpenicillin and gentamicin once a day for 7 days (reference); oral amoxicillin twice daily and intramuscular gentamicin once a day for 7 days; or intramuscular Procaine Benzylpenicillin and gentamicin once a day for 2 days followed by oral amoxicillin twice daily for 5 days. The primary outcome was treatment failure within 7 days of enrolment and the primary analysis was per protocol. We judged experimental treatments as efficacious as the reference if the upper bound of the 95% CI for the difference in treatment failure was less than 5·0. This trial is registered at ClinicalTrials.gov, number NCT01027429. Findings Between Jan 1, 2010, and Dec 26, 2013, 2780 infants were deemed eligible for the trial, of whom 2453 (88%) were enrolled. Because of inadequate clinical follow-up or treatment adherence, 2251 infants were included in the per-protocol analysis. 820 infants (747 per protocol) were assigned the reference treatment of Procaine Benzylpenicillin and gentamicin, 816 (751 per protocol) were allocated amoxicillin and gentamicin, and 817 (753 per protocol) were assigned Procaine Benzylpenicillin, gentamicin, and amoxicillin. Treatment failure within 7 days of enrolment was reported in 90 (12%) infants who received Procaine Benzylpenicillin and gentamicin (reference), 76 (10%) of those given amoxicillin and gentamicin (risk difference with reference −1·9, 95% CI −5·1 to 1·3), and 99 (13%) of those treated with Procaine Benzylpenicillin, gentamicin, and amoxicillin (risk difference with reference 1·1, −2·3 to 4·5). Interpretation Two simplified antibiotic regimens requiring fewer injections are equivalent to a reference treatment for young infants with signs of clinical severe infection but without signs of critical illness. The use of these simplified regimens has the potential to increase access to treatment for sick young infants who cannot be referred to hospital. Funding The Saving Newborn Lives initiative of Save the Children, through support from the Bill & Melinda Gates, and by WHO and USAID.
Dipak K Mitra - One of the best experts on this subject based on the ideXlab platform.
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Projahnmo Study Group in Bangladesh* Summary
2016Co-Authors: Abdullah H Baqui, Samir K Saha, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K Mitra, Nazma BegumAbstract:Safety and effi cacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence tria
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safety and efficacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible a randomised open label equivalence trial
The Lancet Global Health, 2015Co-Authors: Abdullah H Baqui, Samir K Saha, A Nawshad Uddin S M Ahmed, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K MitraAbstract:Methods We did this randomised, open-label, equivalence trial in four urban hospitals and one rural fi eld site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar effi cacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratifi ed randomisation by study site and age (<7 days or 7–59 days) using computer-generated randomisation sequences. The standard treatment was intramuscular Procaine Benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular Procaine Benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a prespecifi ed similarity margin of 5% to assess equivalence between regimens. This study is registered with ClinicalTrials.gov, number NCT00844337. Findings Between July 1, 2009, and June 30, 2013, we recruited 2490 young infants into the trial. We assigned 830 infants to group A, 831 infants to group B, and 829 infants to group C. 2367 (95%) infants fulfi lled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk diff erence –1·5%, 95% CI –4·3 to 1·3) and 64 (8%) of 790 infants in group C (–1·7%, –4·5 to 1·1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C).
Abdullah H Baqui - One of the best experts on this subject based on the ideXlab platform.
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Projahnmo Study Group in Bangladesh* Summary
2016Co-Authors: Abdullah H Baqui, Samir K Saha, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K Mitra, Nazma BegumAbstract:Safety and effi cacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence tria
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safety and efficacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible a randomised open label equivalence trial
The Lancet Global Health, 2015Co-Authors: Abdullah H Baqui, Samir K Saha, A Nawshad Uddin S M Ahmed, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K MitraAbstract:Methods We did this randomised, open-label, equivalence trial in four urban hospitals and one rural fi eld site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar effi cacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratifi ed randomisation by study site and age (<7 days or 7–59 days) using computer-generated randomisation sequences. The standard treatment was intramuscular Procaine Benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular Procaine Benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a prespecifi ed similarity margin of 5% to assess equivalence between regimens. This study is registered with ClinicalTrials.gov, number NCT00844337. Findings Between July 1, 2009, and June 30, 2013, we recruited 2490 young infants into the trial. We assigned 830 infants to group A, 831 infants to group B, and 829 infants to group C. 2367 (95%) infants fulfi lled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk diff erence –1·5%, 95% CI –4·3 to 1·3) and 64 (8%) of 790 infants in group C (–1·7%, –4·5 to 1·1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C).
Fatima Mir - One of the best experts on this subject based on the ideXlab platform.
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simplified antibiotic regimens for treatment of clinical severe infection in the outpatient setting when referral is not possible for young infants in pakistan simplified antibiotic therapy trial satt a randomised open label equivalence trial
The Lancet Global Health, 2017Co-Authors: Fatima Mir, Imran Nisar, Shiyam Sundar Tikmani, Benazir Baloch, Sadia Shakoor, Fyezah Jehan, Imran Ahmed, Simon Cousens, Anita K M ZaidiAbstract:Summary Background Parenteral antibiotic therapy for young infants (aged 0–59 days) with suspected sepsis is sometimes not available or feasible in countries with high neonatal mortality. Outpatient treatment could save lives in such settings. We aimed to assess the equivalence of two simplified antibiotic regimens, comprising fewer injections and oral rather than parenteral administration, compared with a reference treatment for young infants with clinical severe infection. Methods We undertook the Simplified Antibiotic Therapy Trial (SATT), a three-arm, randomised, open-label, equivalence trial in five communities in Karachi, Pakistan. We enrolled young infants (aged 0–59 days) who either presented at a primary health-care clinic or were identified by a community health worker with signs of clinical severe infection. We included infants who were not critically ill and whose family refused admission. We randomly assigned infants to either intramuscular Procaine Benzylpenicillin and gentamicin once a day for 7 days (reference); oral amoxicillin twice daily and intramuscular gentamicin once a day for 7 days; or intramuscular Procaine Benzylpenicillin and gentamicin once a day for 2 days followed by oral amoxicillin twice daily for 5 days. The primary outcome was treatment failure within 7 days of enrolment and the primary analysis was per protocol. We judged experimental treatments as efficacious as the reference if the upper bound of the 95% CI for the difference in treatment failure was less than 5·0. This trial is registered at ClinicalTrials.gov, number NCT01027429. Findings Between Jan 1, 2010, and Dec 26, 2013, 2780 infants were deemed eligible for the trial, of whom 2453 (88%) were enrolled. Because of inadequate clinical follow-up or treatment adherence, 2251 infants were included in the per-protocol analysis. 820 infants (747 per protocol) were assigned the reference treatment of Procaine Benzylpenicillin and gentamicin, 816 (751 per protocol) were allocated amoxicillin and gentamicin, and 817 (753 per protocol) were assigned Procaine Benzylpenicillin, gentamicin, and amoxicillin. Treatment failure within 7 days of enrolment was reported in 90 (12%) infants who received Procaine Benzylpenicillin and gentamicin (reference), 76 (10%) of those given amoxicillin and gentamicin (risk difference with reference −1·9, 95% CI −5·1 to 1·3), and 99 (13%) of those treated with Procaine Benzylpenicillin, gentamicin, and amoxicillin (risk difference with reference 1·1, −2·3 to 4·5). Interpretation Two simplified antibiotic regimens requiring fewer injections are equivalent to a reference treatment for young infants with signs of clinical severe infection but without signs of critical illness. The use of these simplified regimens has the potential to increase access to treatment for sick young infants who cannot be referred to hospital. Funding The Saving Newborn Lives initiative of Save the Children, through support from the Bill & Melinda Gates, and by WHO and USAID.
Samir K Saha - One of the best experts on this subject based on the ideXlab platform.
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Projahnmo Study Group in Bangladesh* Summary
2016Co-Authors: Abdullah H Baqui, Samir K Saha, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K Mitra, Nazma BegumAbstract:Safety and effi cacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence tria
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safety and efficacy of alternative antibiotic regimens compared with 7 day injectable Procaine Benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible a randomised open label equivalence trial
The Lancet Global Health, 2015Co-Authors: Abdullah H Baqui, Samir K Saha, A Nawshad Uddin S M Ahmed, Mohammad Shahidullah, Iftekhar Quasem, Daniel E Roth, A K M Samsuzzaman, Wazir Ahmed, S Shahnawaz Bin M Tabib, Dipak K MitraAbstract:Methods We did this randomised, open-label, equivalence trial in four urban hospitals and one rural fi eld site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar effi cacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratifi ed randomisation by study site and age (<7 days or 7–59 days) using computer-generated randomisation sequences. The standard treatment was intramuscular Procaine Benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular Procaine Benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a prespecifi ed similarity margin of 5% to assess equivalence between regimens. This study is registered with ClinicalTrials.gov, number NCT00844337. Findings Between July 1, 2009, and June 30, 2013, we recruited 2490 young infants into the trial. We assigned 830 infants to group A, 831 infants to group B, and 829 infants to group C. 2367 (95%) infants fulfi lled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk diff erence –1·5%, 95% CI –4·3 to 1·3) and 64 (8%) of 790 infants in group C (–1·7%, –4·5 to 1·1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C).