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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.