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Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

ABSTRACT: Infection in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. Timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alternative, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives.This trial aims to determine whether 2 simplified antibiotic regimens are equivalent to the reference therapy with 7 days of once-daily (OD) intramuscular (IM) procaine penicillin and gentamicin for outpatient management of young infants with clinically presumed systemic bacterial infection treated in primary health-care clinics in 5 communities in Karachi, Pakistan. The reference regimen is close to the current recommendation of the hospital-based intravenous ampicillin and gentamicin therapy for neonatal sepsis. The 2 comparison arms are (1) IM gentamicin OD and oral amoxicillin twice daily for 7 days; and (2) IM penicillin and gentamicin OD for 2 days, followed by oral amoxicillin twice daily for 5 days; 2250 "evaluable" infants will be enrolled. The primary outcome of this trial is treatment failure (death, deterioration or lack of improvement) within 7 days of enrollment. Results are expected by early 2014.This trial will determine whether simplified antibiotic regimens with fewer injections in combination with high-dose amoxicillin are equivalent to 7 days of IM procaine penicillin and gentamicin in young infants with clinical severe infection. Results will have program and policy implications in countries with limited access to hospital care and high burden of neonatal deaths.

SUBMITTER: Zaidi AK

PROVIDER: S-EPMC3814935 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

Zaidi Anita K M AK Tikmani Shiyam Sundar SS Sultana Shazia S Baloch Benazir B Kazi Momin M Rehman Hamidur H Karimi Khairunnissa K Jehan Fyezah F Ahmed Imran I Cousens Simon S

The Pediatric infectious disease journal 20130901

<h4>Background</h4>Infection in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. Timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alternative, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives.<h4>Methods</h4>This trial aims to determine whether 2 simplified antibio ...[more]

PMID: 23945571

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Project description:BackgroundParenteral 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.

Project description:BACKGROUND: Secondary infertility in developing countries is mostly attributable to blockage of the fallopian tubes due to adhesions caused by reproductive tract infections. There is a dearth of information on the prevalence and causes of secondary infertility from Pakistan. This paper presents results on factors associated with secondary infertility among married women in Karachi, Pakistan. METHODS: A matched case-control study was conducted. Cases were women aged 15-35 years with history of at least one previous conception and currently seeking treatment for secondary infertility. Controls were women residing in the neighborhood of cases with at least one live birth and not taking treatment for secondary infertility. The age of controls was matched by ±5 years to that of cases. Data was collected from June to August 2003. Conditional logistic regression was used to determine crude and adjusted odds ratios (OR) with corresponding 95% confidence intervals (CI) for factors associated with secondary infertility. RESULTS: The final multivariate logistic regression model revealed that after adjusting for age, cases were more likely to be the housewives (AOR = 2.6, 95% CI:1.5-4.4), had used inappropriate material to absorb blood during menstruation (AOR = 9.0, 95% CI: 5.0-16.4), and at their last delivery, had a birth attendant who did not wash hands with soap and water (AOR = 3.0, 95% CI: 1.4-5.7). Moreover, women with secondary infertility were more likely to report current or past history of having STI symptoms (AOR = 3.6, 95% CI: 2.4-5.6) and use of intra-vaginal indigenous medicines during their last post-partum period (AOR = 3.1, 95% CI: 1.6-5.7). CONCLUSION: We recommend health education and awareness messages for safe practices during menstruation, delivery, and the postpartum period for women in general. Additionally, sanitary napkins should be made available at an affordable cost, and safe delivery kits should contain educational/pictorial brochures for appropriate hand washing skills.

Dataset Information

Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

Publications

Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

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