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

Volumn 3, Issue 5, 2015, Pages e279-e287

  Baqui, Abdullah H ^a   Saha, Samir K ^b   Ahmed, A S M Nawshad Uddin ^b   Shahidullah, Mohammad ^c   Quasem, Iftekhar ^b   Roth, Daniel E ^d   Samsuzzaman, A K M ^e   Ahmed, Wazir ^f   Tabib, S M Shahnawaz Bin ^g   Mitra, Dipak K ^a   Begum, Nazma ^a   Islam, Maksuda ^b   Mahmud, Arif ^a   Rahman, Mohammad Hefzur ^a   Moin, Mamun Ibne ^a   Mullany, Luke C ^a   Cousens, Simon ^h   El Arifeen, Shams ⁱ   Wall, Stephen ^j   Brandes, Neal ^k   Santosham, Mathuram ^a   Black, Robert E ^a   more..

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b DHAKA SHISHU HOSPITAL   (Bangladesh)

^c Department of Gastroenterology   (Bangladesh)

^d HOSPITAL FOR SICK CHILDREN   (Canada)

^e Shishu Sasthya Foundation   (Bangladesh)

^f Chittagong Ma O' Shishu Hospital   (Bangladesh)

^g Institute of Child and Mother Health Dhaka bd   (Bangladesh)

^h LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

ⁱ INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH   (Bangladesh)

^j SAVE THE CHILDREN   (United States)

^k UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN; GENTAMICIN; PROCAINE PENICILLIN; ANTIINFECTIVE AGENT;

ARTICLE; CLINICAL ASSESSMENT; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; HEALTH CARE PERSONNEL; HUMAN; INFANT; INFECTION; MAJOR CLINICAL STUDY; NEWBORN CARE; OUTCOME ASSESSMENT; PATIENT REFERRAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; BACTERIAL INFECTIONS; CONTROLLED STUDY; FEMALE; INDIA; INTRAMUSCULAR DRUG ADMINISTRATION; MALE; NEWBORN; ORAL DRUG ADMINISTRATION; THERAPEUTIC EQUIVALENCE; TREATMENT FAILURE;

ADMINISTRATION, ORAL; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; FEMALE; GENTAMICINS; HUMANS; INDIA; INFANT; INFANT, NEWBORN; INJECTIONS, INTRAMUSCULAR; MALE; PENICILLIN G PROCAINE; THERAPEUTIC EQUIVALENCY; TREATMENT FAILURE;

EID: 84927911880     PISSN: None     EISSN: 2214109X     Source Type: Journal    
DOI: 10.1016/S2214-109X(14)70347-X     Document Type: Article

References (31)

1. Lawn JE, Kerber K, Enweronu-Laryea C, Massee Bateman O Newborn survival in low resource settings-are we delivering?. BJOG 2009, 116(suppl 1):49-59.
2. Liu L, Johnson HL, Cousens S, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet 2012, 379:2151-2161.
3. Bryce J, Boschi-Pinto C, Shibuya K, Black RE WHO estimates of the causes of death in children. Lancet 2005, 365:1147-1152. the WHO Child Health Epidemiology Reference Group.
4. Bhutta ZA, Darmstadt GL, Hasan BS, Haws RA Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics 2005, 115(2 suppl):519-617.
5. Stoll BJ The global impact of neonatal infection. Clin Perinatol 1997, 24:1-21.
6. Mullany LC, Darmstadt GL, Khatry SK, et al. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet 2006, 367:910-918.
7. Arifeen SE, Mullany LC, Shah R, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet 2012, 379:1022-1028.
8. Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet 2012, 379:1029-1036.
9. Bang AT, Paul VK, Reddy HM, Baitule SB Why do neonates die in rural Gadchiroli, India? (Part I): primary causes of death assigned by neonatologist based on prospectively observed records. J Perinatol 2005, 25(suppl 1):S29-S34.
10. Baqui AH, Arifeen SE, Williams EK, et al. Effectiveness of home-based management of newborn infections by community health workers in rural Bangladesh. Pediatr Infect Dis J 2009, 28:304-310.
11. Baqui AH, Darmstadt GL, Williams EK, et al. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programs. Bull World Health Organ 2006, 84:706-713.
12. Hoque DM, Rahman M, Billah SM, et al. An assessment of the quality of care for children in eighteen randomly selected district and subdistrict hospitals in Bangladesh. BMC Pediatr 2012, 12:197.
13. Mbwele B, Reddy E, Reyburn H A rapid assessment of the quality of neonatal healthcare in Kilimanjaro region, northeast Tanzania. BMC Pediatr 2012, 12:182.
14. Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet 1999, 354:1955-1961.
15. Save the Children, Saving Newborn Lives, USAID World Health Organization. Expert Consultation on Community-Based Approaches for Neonatal Sepsis Management September 26-28, 2007, meeting report 2008, Save the Children, Saving Newborn Lives, USAID World Health OrganizationUSAID World Health Organization, Save the Children, Saving Newborn Lives, USAID, World Health Organization, London.
16. Khanal S, Sharma J, GC VS, et al. Community health workers can identify and manage possible infections in neonates and young infants: MINI-a model from Nepal. J Health Popul Nutr 2011, 29:255-264.
17. Bang AT, Bang RA, Reddy MH Simple clinical criteria to identify sepsis or pneumonia in neonates in the community needing treatment or referral. Pediatr Infect Dis J 2005, 24:335-341.
18. Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bull World Health Organ 1999, 77:789-800.
19. Hazir T, Fox LM, Nisar YB, et al. Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial. Lancet 2008, 371:49-56.
20. Baqui AH, Saha SK, Ahmed AS, et al. Safety and efficacy of simplified antibiotic regimens for outpatient treatment of serious infection in neonates and young infants 0-59 days of age in Bangladesh: design of a randomized controlled trial. Pediatr Infect Dis J 2013, 32(suppl 1):S12-S18.
21. Nestaas E, Bangstad HJ, Sandvik L, Wathne KO Aminoglycoside extended interval dosing in neonates is safe and effective: a meta-analysis. Arch Dis Child Fetal Neonatal Ed 2005, 90:F294-F300.
22. Rao SC, Ahmed M, Hagan R One dose per day compared to multiple doses per day of gentamicin for treatment of clinical or proven sepsis in neonates. Cochrane Database Syst Rev 2006, 1. CD005091.
23. Custer JW, Rau RE The Harriet Lane handbook: a manual for pediatric house officers 2009, Mosby, Philadelphia. 18th edn.
24. Cohen J A coefficient of agreement for nominal scales. Educ Psychol Meas 1960, 20:37-46.
25. Blackwelder WC "Proving the null hypothesis" in clinical trials. Control Clin Trials 1982, 3:345-353.
26. Saving Newborn Lives, USAID, WHO. Expert consultation on community-based approaches for neonatal sepsis management; September 26-28, 2007. London: Saving Newborn Lives, USAID, World Health Organization, 2008.
27. AFRINEST study group. Oral amoxicillin compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with fast breathing when referral is not possible: a randomised, open-label, equivalence trial. Lancet 2015, AFRINEST study group, published online April 2. http://dx.doi.org/10.1016/S0140-6736(14)62285-6.
28. AFRINEST study group. Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet 2015, AFRINEST study group, published online April 2. http://dx.doi.org/10.1016/S0140-6736(14)62284-4.
29. Zaidi AK, Tikmani SS, Warraich HJ, et al. Community-based treatment of serious bacterial infections in newborns and young infants: a randomized controlled trial assessing three antibiotic regimens. Pediatr Infect Dis J 2012, 31:667-672.
30. Wall SN, Mazzeo CI, Adejuyigbe EA, et al. Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring. Pediatr Infect Dis J 2013, 32(9 suppl 1):S39-S45.
31. Peterson SI, Nsungwa-Sabiiti J, Were W Coping with pediatric referral-Ugandan parents' experience. Lancet 2004, 363:1955-1956.