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  • HOW CAN MOSQUITOES BE CONTROLLED?

    Mosquitoes around the home can be reduced significantly by minimizing the amount of standing water available for mosquito breeding. Residents are urged to reduce standing water around the home in a variety of ways.

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    The best way is to avoid being bitten by mosquitoes.This can be accomplished using personal protecting  while outdoors when mosquitoes are present. Treated bed nets should be used sleeping. Mosquito repellent should be used when outdoor.

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    Nearly half of the world’s population is at risk of getting malaria. Pregnant women are particularly at risk of malaria. Children under 5 years are at high risk of malaria.
     

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Scaling new heights

Researchers at the Dodowa Health Research Centre (DHRC), in the past few months, have had to surmount various challenges that had to do with logistics, staff capacity, internet and electricity supplies, to join their colleagues across Africa to carry out a phase 4 clinical study into the anti-malaria drug, eurartesim.

Dr Alex Adjei, the Principal Investigator of the eurartesim trial at the DHRC in an interview in Dodowa, said some of the challenges encountered during the study had to do with the largeness of the trial.

This is the first time the site is undertaking such a large clinical study involving over 900 malaria patients recruited as study participants. The site in 2012, undertook a smaller clinical trial into the efficacy of another anti-malarial, artesunate amodiaquine with a smaller number of 200 patients.

Dr Adjei said the site has been engaged in social interventions studies and therefore the largenes of the eurartesim study, came with its own challenges.
The Dodowa site is not well equipped with facilities and equipment. The site is located in the Shai-Osudoku district.

An area just at the periphery of Ghana's capital, Accra. Yet despite this proximity, the community, where the research site operates from, is a largely scattered rural one, which is gradually becoming urbanized with some limited social amenities.

Overcoming these and many other challenges to successfully end the study on the eurartesim drug could be described as another feat accomplished by the site.

Dr Adjei noted that the study provided them with a learning curve in their journey as researchers, adding that as a “growing centre, we had issues with logistics. We had to use 6 facilities but because of good planning we were able to roll out. And then, the second thing is that as any growing centre, the capacity of the staff was also a problem but that is where leadership will have to come in and give roles to people who can do the work. Then, there was the problem with the internet and electricity bit.”

He said the site did not have a laboratory of its own and had to use the laboratory belonging to the Shai-Osudoku District hospital. Dr Adjei stressed the usefulness of the phase 4 study pointing out that it was helpful in providing the baseline for future studies.

“If we have any study in the future, we know how to prepare for it. Now because of the eurartesim study that we did, we are now building our own laboratory, which is going to be situated right at this centre. So we do not need to depend on the hospital for the laboratory facility. This is very good for us. It will make us more independent. It will make us control our own reagents....”

He said the study taught the staff what to do when handling large clinical data because this was a very intense study where they had to pay attention to details, adding that the experience
they had developed would help them to train field workers on safety rules and other issues.

Dr Adjei stated that the eurartesim study officially ended in April 2014 but as part of the processes of closing the trial, the site monitor would have to ensure that files used in the study are appropriately kept in a storage room and the final report on the study written.
He said the report would be sent to regulatory bodies such as the Institutional Review Board of the site and the Ethics Committee of the Ghana Health Service (GHS) to inform them about what has been done. Publications are also expected to follow to publicize the findings of the study to stakeholders.

He said initial analysis of some of the data gathered during the study showed that eurartesim has no effect on the heart or kidney and explained that “we needed to know if it is as safe as artemether-lumefantrine (ALu) and artesunate-amodiaquine (AA).”

During the initial phase of the INESS project about 5 years ago, the earlier ACTs such as AA and ALu were evaluated in Ghana and Tanzania after administering the drugs on patients confirmed with malaria who were then followed up for data collection on the efficacy and effectiveness of these drugs in treating patients.

This second part of the INESS project carried out on the eurartesim drug was targeted at 10,000 patients in Ghana, Burkina Faso, Tanzania and Mozambique after giving them the drug and following up with monitoring to enable the researchers pick up the safety data of the drug. A smaller group, numbering about a 1,000, out of the 10,000 participants was clinically scrutinized further in what was termed as the nested trial by examining their blood samples, testing their internal organs like the liver, kidney and heart functions and carrying out electrocardiogram investigations.

Dr Adjei said although there were some concerns that the drug had some reactions on the heart, there was no rare adverse heart problem picked up in the Dodowa centre, adding that one or two problems were picked up in other sites which were documented and are being analysed to see if it is related to the drug.

Mr Jerry Anan, field supervisor and research officer at the DHRC, said the field workers and others who worked on the project were taken through training by the Food and Drugs Authority (FDA) on good clinical practice to ensure that the study met internationally approved trials.

He said the 6 health facilities used as recruiting centres for the study participants are the Shai-Osudoku District Hospital, Prampram Polyclinic, Dangbe Community Hospital, Ningo Health Centre, St. Andrews Clinic and the Osudoku Health Centre.

He spoke about some challenges encountered during the study and said some study participants in the nested group complained about the long stay at the hospital for tests to be carried out on their heart, liver and kidneys. A small amount of blood was drawn on different occasions to check the functioning of these organs, the presence of malaria parasites and levels of the eurartesim drug in the blood.

Mr Anan said they had to use the local dialect to talk to the patients to explain to them the benefits of the study, adding that they needed to take about 5-7 blood draws and this was a real challenge since some participants believed the blood was being used for other purposes other than for the study.

Mr Solomon Narh-Bana, Coordinator of the eurartesim trial at the site, explained the processes involved in closing up the study and said before closing, the monitor needs to follow up on the agreed protocols, check on the samples collected from each of the study participants, check for consistency and account for drugs used in the study by ensuring that packages of eurartesim left after administering the drugs to participants are handed over.

He said all documentations related to the trials such as the case report forms used to collect the data from the participants have been properly filed, archived and would be kept for a minimum of five years before being discarded.

By Eunice Menka-Ghana

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