Community-based Treatment of Serious Bacterial Infections in Newborns and Young Infants

Zaidi, Anita K. M.; Tikmani, Shiyam Sunder; Warraich, Haider J.; Darmstadt, Gary L.; Bhutta, Zulfiqar A; Sultana, Shazia; Thaver, Durrane

doi:10.1097/inf.0b013e318256f86c

Cited by 76 publications

(80 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, up to three-quarters of families of sick young infants in Karachi, Pakistan, refuse hospital referrals, despite free transport and treatment, because of the substantial opportunity costs to very poor families of prolonged admissions at locations far from their place of residence 3 . Stated reasons for refusal are financial constraints, cultural beliefs, and concern about poor quality of care at hospitals 3, 4. Similar constraints to optimum care of sick newborn babies in high-mortality settings have also been noted from other low-resource settings 5 …”

Section: Introductionmentioning

confidence: 99%

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

Mir

Nisar

Tikmani

et al. 2017

The Lancet Global Health

View full text Add to dashboard Cite

SummaryBackgroundParenteral 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.MethodsWe 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.FindingsBetween 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).InterpretationTwo 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.FundingThe Saving Newborn Lives initiative of Save the Children, through support from the Bill & Melinda Gates, and by WHO and USAID.

show abstract

Section: Introductionmentioning

confidence: 99%

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

Mir

Nisar

Tikmani

et al. 2017

The Lancet Global Health

View full text Add to dashboard Cite

show abstract

“…There is variation in reported incidence of neonatal pSBI, which might be affected by differences in diagnostic criteria and case-finding strategies, as well as by true differences between populations 21 . In studies from India, 22,23 Bangladesh, 24–26 Pakistan, 27 and Nepal, 28,29 pSBI incidence risks range from 50 cases to 217 cases per 1000 livebirths.…”

Section: Introductionmentioning

confidence: 99%

Estimates of possible severe bacterial infection in neonates in sub-Saharan Africa, south Asia, and Latin America for 2012: a systematic review and meta-analysis

Seale

Blencowe

Manu

et al. 2014

The Lancet Infectious Diseases

263

212

View full text Add to dashboard Cite

SummaryBackgroundBacterial infections are a leading cause of the 2·9 million annual neonatal deaths. Treatment is usually based on clinical diagnosis of possible severe bacterial infection (pSBI). To guide programme planning, we have undertaken the first estimates of neonatal pSBI, by sex and by region, for sub-Saharan Africa, south Asia, and Latin America.MethodsWe included data for pSBI incidence in neonates of 32 weeks' gestation or more (or birthweight ≥1500 g) with livebirth denominator data, undertaking a systematic review and forming an investigator group to obtain unpublished data. We calculated pooled risk estimates for neonatal pSBI and case fatality risk, by sex and by region. We then applied these risk estimates to estimates of livebirths in sub-Saharan Africa, south Asia, and Latin America to estimate cases and associated deaths in 2012.FindingsWe included data from 22 studies, for 259 944 neonates and 20 196 pSBI cases, with most of the data (18 of the 22 studies) coming from the investigator group. The pooled estimate of pSBI incidence risk was 7·6% (95% CI 6·1–9·2%) and the case-fatality risk associated with pSBI was 9·8% (7·4–12·2). We estimated that in 2012 there were 6·9 million cases (uncertainty range 5·5 million–8·3 million) of pSBI in neonates needing treatment: 3·5 million (2·8 million–4·2 million) in south Asia, 2·6 million (2·1 million–3·1 million) in sub-Saharan Africa, and 0·8 million (0·7 million–1·0 million) in Latin America. The risk of pSBI was greater in boys (risk ratio 1·12, 95% CI 1·06–1·18) than girls. We estimated that there were 0·68 million (0·46 million–0·92 million) neonatal deaths associated with pSBI in 2012.InterpretationThe need-to-treat population for pSBI in these three regions is high, with ten cases of pSBI diagnosed for each associated neonatal death. Deaths and disability can be reduced through improved prevention, detection, and case management.FundingThe Wellcome Trust and the Bill & Melinda Gates Foundation through grants to Child Health Epidemiology Reference Group (CHERG) and Save the Children's Saving Newborn Lives programme.

show abstract

“…With regards to community management of neonatal sepsis and pneumonia with antibiotics (cotrimoxazole, ampicillin or penicillin) versus no antibiotics, treatment with antibiotics resulted in a significant reduction in all-cause neonatal mortality (RR 0.73; 95% CI: 0.65 to 0.82) [289] and pneumonia-specific mortality (RR 0.58; 95% CI: 0.43 to 0.78) [289]. A study by Zaidi et al [290] stated that among 434 (61.6%) infants recruited at clinics randomized to 7 d of antibiotic therapy, there were 9% failures with penicillin-gentamicin, 15% with ceftriaxone and 18% with Trimethoprim-sulfamethaxole-gentamicin (TMP-SMX-gentamicin). Treatment failure was significantly higher with TMP-SMX-gentamicin compared with penicillin-gentamicin (RR 2.03; 95% CI: 1.09 to 3.79).…”

Section: Management Of Neonatal Pneumonia and Sepsismentioning

confidence: 99%

The interconnections between maternal and newborn health – evidence and implications for policy

Lassi

Majeed

Rashid

et al. 2013

The Journal of Maternal-Fetal & Neonatal Medicine

Self Cite

View full text Add to dashboard Cite

The past decade has witnessed increasing global attention and political support for maternal, newborn and child health. Despite this increased attention, actual progress has been slow and sporadic: coverage of key maternal and newborn health interventions remains low and there are wide disparities in access to care, within and across countries. Strategies for improving maternal and newborn health are closely linked, and can be delivered most effectively through a continuum of care approach. While these interventions are largely known, there is little information on which interventions have a positive health impact for both women and newborns. This supplement identifies the interventions during the preconception, pregnancy, intrapartum and postnatal periods found to have a positive, synergistic effect on maternal and neonatal outcomes. These interventions are then grouped into packages of care for delivery at the community, health center or hospital levels.

show abstract

Community-based Treatment of Serious Bacterial Infections in Newborns and Young Infants

Cited by 76 publications

References 12 publications

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

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

Estimates of possible severe bacterial infection in neonates in sub-Saharan Africa, south Asia, and Latin America for 2012: a systematic review and meta-analysis

The interconnections between maternal and newborn health – evidence and implications for policy

Contact Info

Product

Resources

About