Trial Outcomes & Findings for Chloroquine and Post Malaria Anaemia Study (NCT NCT00473837)

NCT ID: NCT00473837

Last Updated: 2014-10-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2014-10-13

Participant Flow

Participant milestones

Measure	Treatment Subjects initially treated with Corartemether or Cholroquine \& Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.	Control Subjects initially treated with Co-artemether or Cholroquine \& Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
Overall Study STARTED	50	46
Overall Study COMPLETED	49	43
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chloroquine and Post Malaria Anaemia Study

Baseline characteristics by cohort

Measure	Treatment n=50 Participants Subjects initially treated with Co-artemether or Chloroquine \&Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90	Control n=46 Participants Subjects initially treated with Co-artemether or Chloroquine \& Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41.9 months STANDARD_DEVIATION 18.1 • n=5 Participants	38.7 months STANDARD_DEVIATION 17.8 • n=7 Participants	40.3 months STANDARD_DEVIATION 17.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Gambia	50 participants n=5 Participants	46 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure	Treatment n=49 Participants Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90 Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days	Control n=43 Participants Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90 Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul
Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms	93.4 g/L Standard Deviation 9.6	93.7 g/L Standard Deviation 10.2

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mrs Vivat Thomas-Njie

Medical Research Council Unit, The Gambia

Phone: +220-4495442/6

Email: vthomas@mrc.gm

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place