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Table 4 List of amendment until to date

From: Improving the radical cure of vivax malaria (IMPROV): a study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens

Amendment number Protocol version no Changes
1 V 1.1 • Amendments in response to OXTREC, HREC comments
2 V 2.1 and V 2.2 • Updated visit schedule
3 V 2.11 to V2.15 • Maximum number of symptomatic recurrences limited to 4 then supervised open PQ will be given
• Primaquine also to be given supervised for 14 days at the appropriate dose to all participants with at least 1 symptomatic or asymptomatic relapse at the end of the study
• Option for telephoning subjects to run though symptom checklist
• Patients can be enrolled into the study on the basis of a positive RDT for malaria, as per site local practice
• Amend haematological warning signs & management of acute haemolysis
4 V 2.16 • Inclusion of flow cytometry in addition to the currently proposed G6PD tests
5 V 2.16-3.0 • Removal of taking a drug with antimalarial activity during the study as reason to withdraw patient
• Add exclusion criterion – cannot be enrolled in IMPROV twice
• Exclusion criteria removed: women planning to become pregnant & previous use of antimalarial drugs
• G6PD status to be decided on basis of spot test only
• Methaemoglobin to be measured at selected sites only and rotated
• Assent form amended to include weekly PQ regimen
• HemoCue sampling increased in both arms
• Maximum number of symptomatic recurrences in Vietnam – 3 within first 6 months – added to the consent form but will be for Vietnam only
• Adjustment to dosing table for those weighing 17 kg
6 V 4.0 • Addition of Ethiopia
• G6PD substudy with consent form added as an appendix
• Study schedule amended accordingly to accommodate additional G6PD testing
• Clarity added on PK sampling on D7 & 14 – now to be done pre & post dose
7 V 5.0 • Update list of investigator and affiliations
• Remove site in Pakistan and add the 2nd site in Ethiopia
• Revise AE reporting to grades 3 and 4 only
• Revise management of patients with anemia related adverse events & management of acute haemolysis