Comparison of 3 Days Amoxicillin Versus 5 Days Co-Trimoxazole for Treatment of Fast-breathing Pneumonia by Community Health Workers in Children Aged 2-59 Months in Pakistan: A Cluster-randomized Trial.

BACKGROUND: Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level. METHODS: We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2-59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol. RESULTS: Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%, 95% confidence interval [CI] -7.4--3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6-4.1%). No deaths or serious adverse events occurred. CONCLUSIONS: A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2-59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance. CLINICAL TRIALS REGISTRATION: ISRCTN10618300.

Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial.

BACKGROUND: First dose oral co-trimoxazole and referral are recommended for WHO-defined severe pneumonia. Difficulties with referral compliance are reported in many low-resource settings, resulting in low access to appropriate treatment. The objective in this study was to assess whether community case management by lady health workers (LHWs) with oral amoxicillin in children with severe pneumonia was equivalent to current standard of care. METHODS: In Haripur district, Pakistan, 28 clusters were randomly assigned with stratification in a 1:1 ratio to intervention and control clusters by use of a computer-generated randomisation sequence. Children were included in the study if they were aged 2-59 months with WHO-defined severe pneumonia and living in the study area. In the intervention clusters, community-based LHWs provided mothers with oral amoxicillin (80-90 mg/kg per day or 375 mg twice a day for infants aged 2-11 months and 625 mg twice a day for those aged 12-59 months) with specific guidance on its use. In control clusters, LHWs gave the first dose of oral co-trimoxazole (age 2-11 months, sulfamethoxazole 200 mg plus trimethoprim 40 mg; age 12 months to 5 years, sulfamethoxazole 300 mg plus trimethoprim 60 mg) and referred the children to a health facility for standard of care. Participants, carers, and assessors were not masked to treatment assignment. The primary outcome was treatment failure by day 6. Analysis was per protocol with adjustment for clustering within groups by use of generalised estimating equations. This study is registered, number ISRCTN10618300. FINDINGS: We assigned 1995 children to treatment in 14 intervention clusters and 1477 in 14 control clusters, and we analysed 1857 and 1354 children, respectively. Cluster-adjusted treatment failure rates by day 6 were significantly reduced in the intervention clusters (165 [9%] vs 241 [18%], risk difference -8·9%, 95% CI -12·4 to -5·4). Further adjustment for baseline covariates made little difference (-7·3%, -10·1 to -4·5). Two deaths were reported in the control clusters and one in the intervention cluster. Most of the risk reduction was in the occurrence of fever and lower chest indrawing on day 3 (-6·7%, -10·0 to -3·3). Adverse events were diarrhoea (n=4) and skin rash (n=1) in the intervention clusters and diarrhoea (n=3) in the control clusters. INTERPRETATION: Community case management could result in a standardised treatment for children with severe pneumonia, reduce delay in treatment initiation, and reduce the costs for families and health-care systems. FUNDING: United States Agency for International Development (USAID).

Contribution of community health workers to improving access to timely and appropriate case management of childhood fever in Mozambique.

BACKGROUND: Large scale evaluations in several settings have demonstrated that lay community health workers can be trained to provide quality case management of childhood illnesses. In 2010, Mozambique introduced the integrated community case management (iCCM) strategy to reach children in remote areas with care provided through Agentes Polivalentes Elementares (APEs). We assessed the contribution of the program to improved care-seeking and appropriate treatment of childhood febrile illness in Nampula Province. METHODS: We used a post-test quasi-experimental design with three intervention and one comparison districts to compare access and appropriateness of care for sick children in Nampula province. We carried out a household survey in the study districts to measure levels of care-seeking and treatment of childhood fever after approximately two years of full implementation of the iCCM program in the intervention districts. We also assessed consistency of care with standard case management protocols comparing children receiving care from (APEs) to those receiving care from first-level health facilities. RESULTS: A total of 773 children 6-59 months with fever in the last two weeks were included in the study. In iCCM served areas, APEs were the predominant source of care and treatment; 87.1% (95% confidence interval CI 80.8-93.4) of children 6-59 months with fever who sought care were taken first to an APE and APEs accounted for 86.2% (95% CI 79.7-92.7) of all first-line antimalarial treatments. Public health facilities were the leading source of care in comparison areas, providing care to 86.1% (95% CI 79.0-93.3) of children with fever taken for care outside the home. Timeliness of treatment was significantly better in intervention areas, where 63.9% (95% CI 54.4-73.3) of children received treatment within 24 hours of symptom onset compared to 37.5% (95% CI 31.1-43.9) in comparison areas. Children taken first to an APE were more likely to receive a rapid diagnostic test (RDT) (68.1%; 95% CI 57.2-79.0) and to have their respiratory rate assessed (60.0%; 95% CI 45.4-74.6) compared to children taken to health facilities (41.4%; 95% CI33.7-49.2 and 19.4%; 95% CI 8.4-30.5, respectively). Overall, 61.3% (95% CI 51.5-71.0) of children with fever receiving care from APEs received the correct drug within 24 hours and for the correct duration compared to 26.0% (95% CI 18.2-33.9) of those receiving care from health facilities. CONCLUSION: iCCM contributed to improved timely and appropriate treatment for fever for children living far from facilities. Trained, supplied and supervised APEs provided care consistent with iCCM protocols and performed significantly better than first level facilities on most measures of adherence to case management protocols. These findings reinforce the need for comprehensive efforts to strengthen the health system in Mozambique to enable reliable support for quality of case management of childhood illness at both health facility and community levels.

Effect of community mobilization on appropriate care seeking for pneumonia in Haripur, Pakistan.

BACKGROUND: Appropriate and timely care seeking reduces mortality for childhood illnesses including pneumonia. Despite over 90 000 Lady Health Workers (LHWs) deployed in Pakistan, whose tasks included management of pneumonia, only 16% of care takers sought care from them for respiratory infections. As part of a community case management trial for childhood pneumonia, community mobilization interventions were implemented to improve care seeking from LHWs in Haripur district, Pakistan. The objective of the study was to increase the number of children receiving treatment for pneumonia and severe pneumonia by Lady Health Workers (LHWs) through community mobilization approaches for prompt recognition and care seeking in 2 to 59 month-old children. METHODS: To assess pneumonia care seeking practices, pre and post-intervention household surveys were conducted in 28 target Union Councils. Formative research to improve existing LHW training materials, job aids and other materials was carried out. Advocacy events were organized, LHWs and male health promoters were trained in community mobilization, non-functional women and male health committees were revitalized and LHWs and male health promoters conducted community awareness sessions. RESULTS: The community mobilization interventions were implemented from April 2008 - December 2009. Project and LHW program staff organized 113 sensitization meetings for opinion leaders, which were attended by 2262 males and 3288 females. The 511 trained LHWs organized 6132 community awareness sessions attended by 50 056 women and 511 male promoters conducted 523 sessions attended by 7845 males. In one year period, the number of LHWs treating pneumonia increased from 11 in April 2008 to 505 in March 2009. The care seeking from LHWs for suspected pneumonia increased from 0.7% in pre-intervention survey to 49.2% in post-intervention survey. CONCLUSION: The increase in care seeking from LHWs benefited the community through bringing inexpensive appropriate care closer to home and reducing burden on overstretched health facilities. The community mobilization interventions led to improvements in appropriate care seeking that would not have been achievable just by strengthening pneumonia case management skills of LHWs. In addition to strengthening skills, community mobilization and behavior change activities should also be included in community case management programmes.