Over the course of the trial, we enrolled 2,388 patients into the study.
Of these, 50 (2.1%) were G6PD deficient cases and there were a total of 802 (34%) recurrences.
Follow ups finished at the end of December in South Sumatra and at the end of February in Vietnam, North Sumatra and Ethiopia.

Altogether, the trial followed up 1,673 patients for 12 months and 391 patients between 3 and 11 months. Thus, and even though some patients were followed for less than 12 months, we have exceeded our primary target of 22,500 person months of follow up. The additional patients recruited will provide power to determine the superiority of both primaquine arms against the placebo arm at each location.

 

1. Database lock preparation
The past few months have seen a flurry of activities for both the sites and the MORU Data Management team as we prepare for database lock. Some database lock activities are listed here:

• Completion of all data entry including the main CRF, screening and enrollment logs, and samples logs
• Resolution of all queries
• Coding of adverse events
• Reconciliation between Serious Adverse Events and Adverse Events
• Reconciliation between the Recurrence log and Recurrence CRFs
• Scanning and sending of CRFs for all enrolled patients to MORU

2. Data entry and data queries
Fantastic effort from the sites who, despite internet connectivity issues, have managed to complete data entry and are now working diligently on query resolution. Metehara is catching up with data entry and expecting to finish by the end of March. As of the latest batch, the sites with pending queries are North Sumatra (142 queries), Arba Minch (149 queries), and Metehara (106 queries). The other sites have resolved all routine queries; however, additional queries might be raised during the reconciliation of AEs/SAEs and malaria recurrences. To aid in analysis, adverse events are being coded according to MedDRA (Medical Dictionary for Regulatory Activities) by the MORU Data Management team. If you experience any issues with the database or query resolution please do not hesitate to contact Htee Khu.

3. CRF archival
In order to ensure safe capture and storage of all clinical record forms (CRF), Htee Khu has been in communication with the sites to oversee and assist with the scanning and sending of the CRFs to the data management coordination centre in Bangkok. The first site to complete all scanning is South Sumatra (Congratulations!) who completed the upload of their 581 CRFs on 19^th March. Jalalabad, Laghman and Vietnam have also started scanning. Arba Minch, Metehara, and North Sumatra will begin the process in the next few weeks. Please contact Htee Khu if you have any questions or encounter any problems.

1. Data cleaning and CRF archival
Please refer to the Data Management update above. 

2. Sample shipping and processing
The last sample shipment should reach MORU in April at the latest. Mehul and Chompoo are liaising with the sites. DNA extraction should be completed within two months of receiving the last shipment.

3. IMPROV Investigator and Stakeholder meeting
We are pleased to confirm that the IMPROV Investigator and Stakeholder meeting will be held on Thursday 9th - Friday 10th August 2018 in Bangkok.
This meeting will bring together key study investigators and stakeholders to discuss the results of the primary analyses and priorities for subsequent analyses and sub-projects.
A Save-the-Date email was sent to all invitees in December 2017 and formal invitations and a draft agenda will soon follow.