Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya (EAPHLNP)
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|ClinicalTrials.gov Identifier: NCT01899820|
Recruitment Status : Unknown
Verified October 2013 by Sabah Ahmed Omar, KEMRI-Wellcome Trust Collaborative Research Program.
Recruitment status was: Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : October 8, 2013
Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs.
This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice.
Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including
- Working towards the standardization of methodologies and common protocols as a way of comparing data across sites
- Pulling together datasets and conduct a multi-centre analysis
- Sharing and coordinating quality assurance mechanisms
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Artemether lumefantrine Drug: Dihydroartemisinin piperaquine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||July 2015|
Active Comparator: Artemether lumefantrine
Tablets, 1-4 tablets (weight calculated dose), BD, at hr 0, 8, 24, 36, 48 and 60.
Drug: Artemether lumefantrine
Artemether 20mg Lumefantrine 120mg
Other Name: Coartem
Experimental: Dihydroartemisinin piperaquine
Tablets, 2 paediatric tablets/1 adult tablet, OD, every 24 hours for 48 hours
Drug: Dihydroartemisinin piperaquine
Dihydroartemisinin 20mg Piperaquine 160mg
Other Name: Duocortexin
- The primary endpoint will be the PCR-corrected and parasitological response (PCR corrected ACPR) at days 28 and 42. Change in this outcome measure will be assessed. [ Time Frame: Day 28 and day 42 ]
ACPR is defined as the absence of parasitaemia on day 42 irrespective of the temperature without previously meeting any of the criteria of early treatment failure or late clinical or parasitological failure.
Patients with late asexual parasite reappearance will be considered ACPR if the CR analyses shows a new infection rather than a recrudescence (through PCR genotyping).
The total treatment failure is defined according to the WHO criteria as the sum of early and late treatment failures.
- Crude (PCR uncorrected) ACPR ratio at day 28 (PCR uncorrected ACPR) [ Time Frame: Day 28 ]
- Cure ratios at day 28, 42, (PCR corrected and PCR uncorrected). Change in this outcome measure will be assessed. [ Time Frame: Day 28 and day 42 ]
- Fever Clearance Time (FCT) [ Time Frame: 0 to 48 hours ]This will be defined as the time (hrs) from the start of a patient's treatment to the first consecutive axillary temp measurements below 37.5 for at least 48 hrs
- Asexual parasite clearance time (PCT) [ Time Frame: Day 0 to day 28, upto day 42 ]PCT(proportion of patients remaining parasitaemic) defined as the time (in hours) from the start of a patient's treatment to 2 consecutive negative blood slides (collected at different days)
- Gametocyte carrier rates and geometric mean densities (excluding negatives) will be compared on days 7, 14, 28 and 42. Change in this outcome measure will be assessed. [ Time Frame: Day 7, 14, 28 and 42 ]
- Changes of haemoglobin (Hb) concentration from day 0 to days 28, and 42 [ Time Frame: Day 0, day 28 and day 42 ]
- Number of participants with adverse events [ Time Frame: Up to day 42 ]
- Comparison between adverse events related to artemether lumefantrine and dihydroartemisinin piperaquine [ Time Frame: Up to day 42 ]
- Temperature [ Time Frame: Up to day 42 ]
- Oxygen saturation [ Time Frame: Up to day 42 ]
- Heart rate [ Time Frame: Up to day 42 ]
- Respiratory rate [ Time Frame: Up to day 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): NCT01899820
|Msambweni sub-district hospital|
|Msambweni, Kwale, Kenya|
|Busia district hospitals|
|Kisii district hospitals|
|Kitale district hospitals|
|Machakos district hospital|
|Malindi district hospitals|
|Nyando district hospital|
|Principal Investigator:||Sabah A Omar, PhD||KEMRI CGMR-C|