Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa

Abstract

Introduction Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0–59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. Methods Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. Results The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4–25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4–23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. Conclusion Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. Clinical trial registration The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.

Can Clean Delivery Kits Prevent Infections? Lessons from Traditional Birth Attendants in Nigeria

“…The cost of local assembly of CDK ($2.20) compared to the lowest average patient cost of treating blood stream infection in neonates in Africa ($20.90) [45] buttresses the cost-effectiveness of a clean delivery kit in preventing infections in these settings. Assessment of clean delivery kit acceptability among the TBAs revealed that the kits were perceived as acceptable, appropriate, and essential items in ensuring clean deliveries.…”

A multi-country implementation research initiative to jump-start scale-up of outpatient management of possible serious bacterial infections (PSBI) when a referral is not feasible: Summary findings and implications for programs

“…In the current PLoS One Neonatal Infection Collection, Garg and colleagues [ 27 ] estimated the costs of treating young infants with PSBI as outpatients when a referral is not possible in low-resource settings using the data from African Neonatal Sepsis Trials (AFRINEST) [ 10 , 11 ]. The weighted average costs across all sites for treating clinical severe infection in 2012 were US$ 25.3 (95% CI US$ 20.4–30.1) per infant treated when the regimen with 7 days of gentamicin plus amoxicillin was used, and US$ 20.9 (95% CI US$16.4–25.3) when the regimen with 2 days gentamicin plus 7 days amoxicillin was used.…”

“…The health system will have a reduced load as issues with quality of care at the hospitals, limited hospital beds, overburdened staff, non-functional equipment, regular supply of commodities, and patient satisfaction are common challenges [ 41 , 42 ], especially in low resource settings. The cost of outpatient treatment is much less than inpatient treatment [ 27 , 43 ]. Moreover, there is less risk of nosocomial infections with outpatient treatment [ 44 , 45 ].…”