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Table 1 Summary of antimalarial clinical trials conducted in Uganda 2002 – 2007

From: Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

Trial Kampala 1 UMSP 1 UMSP 2 UMSP 3 UMSP 4 Kampala 2
Study site(s) Kampala Kyenjojo, Mubende, Kanungu Jinja, Arua, Tororo, Apac Tororo Apac Kampala
Years conducted August 2002 – July 2003 December 2002 – June 2003 November 2002 – May 2004 December 2004 – July 2005 May – July 2006 November 2004 – May 2007
Regimens evaluated* CQ+SP CQ+SP CQ+SP AS+AQ AL AQ+SP
  AQ+SP AQ+SP AQ+SP AL DP AS+AQ
  AS+AQ   AS+AQ    AL
Duration of follow-up 28 days 28 days 28 days 42 days 42 days 42 days
Age range of participants 0.5 – 10 years ≥ 6 months ≥ 6 months 1 – 10 years 0.5 – 10 years 1 – 10 years
Total study treatments 400 1105 2160 408 421 1120 †
Efficacy outcome assigned 384 (96%) 1057 (96%) 2081 (96%) 403 (99%) 417 (99%) 1108 (99%)
Total SAEs 16 41 20 2 6 18
   Convulsions 4 15 4 1 3 9
   Altered mental status 1 0 2 0 0 0
   Anemia 5 6 3 0 0 0
   Vomiting 2 13 1 0 0 1
   Weakness 0 3 1 0 0 2
   Respiratory illness 1 1 4 1 0 2
   Other 3 3 5 0 3 4
  1. * CQ+SP: chloroquine + sulphadoxine-pyrimethamine; AQ+SP: amodiaquine + sulphadoxine-pyrimethamine; AS+AQ: artesunate + amodiaquine; AL: artemether-lumefantrine; DP: dihydroartemisinin-piperaquine
  2. † Of 602 children enrolled into the Kampala 2 cohort study, 382 were diagnosed with at least one episode of uncomplicated malaria and were treated with a total of 1120 study treatments.