title: Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  United States Agency for International Development (USAID).
authors.affiliation: Save the Children US, Pakistan Country Office, Islamabad, Pakistan.
authors.forename: Abdul
authors.initials: A
authors.lastname: Bari
authors.forename: Salim
authors.initials: S
authors.lastname: Sadruddin
authors.forename: Attaullah
authors.initials: A
authors.lastname: Khan
authors.forename: Ibad ul Haque
authors.initials: Iu
authors.lastname: Khan
authors.forename: Amanullah
authors.initials: A
authors.lastname: Khan
authors.forename: Iqbal A
authors.initials: IA
authors.lastname: Lehri
authors.forename: William B
authors.initials: WB
authors.lastname: Macleod
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Fox
authors.forename: Donald M
authors.initials: DM
authors.lastname: Thea
authors.forename: Shamim A
authors.initials: SA
authors.lastname: Qazi
mesh_terms: D000284:Administration, Oral; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019090:Case Management; D002675:Child, Preschool; D016000:Cluster Analysis; D003150:Community Health Workers; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010154:Pakistan; D011014:Pneumonia / Q000175:diagnosis / Q000188:drug therapy*; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage
chemical_list: D000900:Anti-Bacterial Agents; D000658:Amoxicillin; D015662:Trimethoprim, Sulfamethoxazole Drug Combination
references.citation: J Pak Med Assoc. 1997 Jan;47(1):24-8
references.pmid: 9056733
references.citation: Lancet. 2008 Jan 5;371(9606):49-56
references.pmid: 18177775
references.citation: Lancet Infect Dis. 2003 Sep;3(9):547-56
references.pmid: 12954560
references.citation: Lancet. 2008 Sep 6;372(9641):822-30
references.pmid: 18715634
references.citation: Med Anthropol. 1994 May;15(4):335-52
references.pmid: 8041234
references.citation: Bull World Health Organ. 2008 May;86(5):381-9
references.pmid: 18545741
references.citation: J Perinatol. 2011 Sep;31(9):586-92
references.pmid: 21273989
references.citation: Lancet. 2005 Sep 17-23;366(9490):1026-35
references.pmid: 16168785
references.citation: Lancet. 2010 Jun 5;375(9730):1969-87
references.pmid: 20466419
references.citation: Lancet. 2004 Sep 25-Oct 1;364(9440):1141-8
references.pmid: 15451221
references.citation: Bull World Health Organ. 1996;74(5):501-7
references.pmid: 9002330
references.citation: Int J Epidemiol. 2010 Apr;39 Suppl 1:i155-71
references.pmid: 20348118
references.citation: J Pak Med Assoc. 1994 Aug;44(8):185-8
references.pmid: 7996664
references.citation: Soc Sci Med. 1997 Oct;45(7):991-1004
references.pmid: 9257392
references.citation: Trop Med Int Health. 2011 Aug;16(8):995-1006
references.pmid: 21545381
references.citation: Bull World Health Organ. 2008 May;86(5):408-16
references.pmid: 18545744
references.citation: J Pak Med Assoc. 1997 Jan;47(1):29-32
references.pmid: 9056734
references.citation: Health Policy Plan. 2001 Jun;16(2):193-8
references.pmid: 11358921
references.citation: Lancet. 2004 Jun 12;363(9425):1955-6
references.pmid: 15194257
references.citation: Hum Resour Health. 2009 Jul 21;7:59
references.pmid: 19622172
references.citation: Bull World Health Organ. 2008 May;86(5):332-8
references.pmid: 18545734