Improving Anti-malarial Treatment Options in Guinea-Bissau - Part A
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|ClinicalTrials.gov Identifier: NCT01704508|
Recruitment Status : Unknown
Verified December 2013 by Bandim Health Project.
Recruitment status was: Recruiting
First Posted : October 11, 2012
Last Update Posted : December 6, 2013
Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended for the treatment of malaria in Africa. However, artemisinin resistance appears to be developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to be efficacious and well tolerated in several African countries and is therefore such an option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and dihydroartemisinin-piperaquine is therefore needed.
Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria will be informed of the study. If accepting and the child fulfil the inclusion criteria, the child will be randomised to treatment with either AL or DP. The treatment will be given supervised at the health centre in the morning and the evening on day 0, day 1, and day 2.
At each visit and in the morning on day 3, the child will be examined, the mother asked for any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample will be taken for examination of malaria parasites. On day 0 samples for measurement of antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number of leucocytes will also be taken.
After having finished the treatment the children will be followed on day 7 and then once a week until day 42. At each visit the condition of the child will be examined and a bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper bloodsample will be collected for measurement of the drug concentration of if the child has recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will be examined.
The result of the two treatments will be evaluated by comparing the number of children with recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This will be presented as adequate clinical and parasitological response rates PCR-corrected and PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till day 42 will be compared. The concentration of the antimalarial drug in the blood samples taken at the visit before the re-parasitaemia will be capered to the concentrations in children without re-parasitaemia.
Assuming a 20% loss to follow up a total of 346 children should be included. For the children included, health care and medications at Bandim Health Centre will be free during the study period but no other gifts or payments will be made.
Results will be presented to the staff at the Bandim health centre and the ministry of Health and will be published in an international peer reviewed journal.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Artemether-lumefantrine Drug: Dihydroartemisinin-piperaquine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||346 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||January 2015|
Active Comparator: Artemether-lumefantrine
6-dose regime will be used:
Other Name: Coartem (R)
Active Comparator: Dihydroartemisinin-piperaquine
A 3 dose regime will be used
Other Name: Eurartesim
- Adequate clinical and parasitological response rate [ Time Frame: 42 days ]The data will be analysed using survival estimates of per protocol treatment failure rates but also intention to treat treatment failure rates.
- the safety of AL and DP [ Time Frame: 42 days ]Self-reported signs and symptoms, clinical evaluations during treatment, day 7 and then weekly until day 42. leucocytes day 0, 3, 7, 14 and 21.
- To determine the capacity of each drug combination to protect against re-infection and to differentiate recrudescence from re-infections using PCR based methods [ Time Frame: 42 days ]
- Genetic polymorphisms in P. falciparum causing reparasitaemia (by PCR) and in 50 children perform a characterisation of P. falciparum geno- and phenotypes. [ Time Frame: 42 days ]For all children with re-parasitaemia genetic polymorfisms will be established by PCR, and in additional 50 children further characterisation using cultures will be done
- haemoglobin values [ Time Frame: days 0, 3 and 42 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704508
|Contact: Poul-Erik Kofoed, M.D., Ph.D.||+45 76363490 ext firstname.lastname@example.org|
|Contact: Johan Ursing, M.D., Ph.D.||+46 email@example.com|
|Bandim Health Project||Recruiting|
|Contact: Amabelia Rodrigues, MD, ph.d. firstname.lastname@example.org|
|Principal Investigator: Amabelia Rodrigues, MD, ph.d.|