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Antimalarial drug quality in Gabon


- candidate number15966
- NTR NumberNTR4341
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-dec-2013
- Secondary IDs2013.11 
- Public TitleAntimalarial drug quality in Gabon
- Scientific TitleAntimalarial drug quality in Gabon
- ACRONYMAMQUAL
- hypothesisIn Gabon, antimalarial drugs are widely available in both the private as well in the public sector and often self-prescribed (correctly and incorrectly) for the many febrile episodes attributed to malaria. Insufficient facilities to check the quality of antimalarial drugs, poor patient knowledge about these drugs; their relative high costs and the lack of appropriate regulatory and legal actions by the government make these drugs attractive for counterfeiters. Reports of poor quality and falsified drugs have increased in the past decade and evidence that a considerable proportion of drugs consumed in the developing world are of poor quality (often with no active or wrong ingredients) is emerging. Falsified drugs are an immediate threat for public health and have led to a great number of deaths from untreated malaria. For Gabon, there is no (published) data about the quality of available antimalarial drugs. We hypothesize that poor-quality anti-malarial drugs are prevalent in Gabon.
- Healt Condition(s) or Problem(s) studiedMalaria
- Inclusion criteriaAntimalarial drugs that will be purchased, collected and analyzed are:
Amodiaquine; Artemether; Artesunate; Atovaquone; Chloroquine; dihydroartemisinin; Halofantrine; Lumefantrine; Mefloquine; Piperaquine; Primaquine; Proguanil; Pyrimethamine; Pyronaridine; Quinine; Sulfadoxine; Sulfamethoxypyrazine
- Exclusion criterian/a
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 31-dec-2013
- planned closingdate24-jan-2014
- Target number of participants400
- Interventionsn/a (This is a prospective observational drug-quality field survey)
- Primary outcome- Quality of antimalarial drugs in Gabon.
- Secondary outcome- Prevalence of poor quality antimalarial drugs.
- Proportion of outlets selling poor quality medicines.
- Prevalence/availability of antimalarial drugs that are no longer recommended as first or second line treatment in Gabon or by the World Health Organization (WHO).
If possible:
-Proportions of different types of poor quality medicines.
- Risk indicators of poor quality antimalarial drugs.
- Timepoints20-30 December 2013: Pilot study
31 December 2013: Official start of study
24 January 2013: Total targeted sample size collected and transported to laboratory of AMC.
February 2013: Analysis of samples
March 2013: Preparing for publication to peer-reviewed medical journal
- Trial web siten/a
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD Benjamin Jelle Visser
- CONTACT for SCIENTIFIC QUERIESMD Benjamin Jelle Visser
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsAssessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab ® : a field study Benjamin J Visser, Janneke Meerveld-Gerrits, Daniëlle Kroon, Judith Mougoula, Rieke Vingerling, Emmanuel Bache, Jimmy Boersma, Michèle van Vugt, Selidji T Agnandji, Harparkash Kaur and Martin P Grobusch. Malaria Journal 2015, 14:273  doi:10.1186/s12936-015-0795-z

The diagnostic accuracy of the hand-held Raman spectrometer for the identification of anti-malarial drugs. Benjamin J. Visser, Sophia G. de Vries, Emmanuel B. Bache, Janneke Meerveld-Gerrits, Daniëlle Kroon, Jimmy Boersma, Selidji T. Agnandji, Michèle van Vugt and Martin P. Grobusch. Malaria Journal 2016 15:160 DOI: 10.1186/s12936-016-1212-y
- Brief summaryBackground: In Gabon, antimalarial drugs are widely available in both the private as well in the public sector and often self-prescribed (correctly and incorrectly) for the many febrile episodes attributed to malaria. Insufficient facilities to check the quality of antimalarial drugs, poor patient knowledge about these drugs; their relative high costs and the lack of appropriate regulatory and legal actions by the government make these drugs attractive for counterfeiters. Reports of poor quality and falsified drugs have increased in the past decade and evidence that a considerable proportion of drugs consumed in the developing world are of poor quality (often with no active or wrong ingredients) is emerging. Falsified drugs are an immediate threat for public health and have led to a great number of deaths from untreated malaria. For Gabon, there is no (published) data about the quality of available antimalarial drugs. We hypothesize that poor-quality anti-malarial drugs are prevalent in Gabon. Objective: To describe the quality of available antimalarial drugs and to determine the prevalence of poor quality antimalarial drugs in Gabon. Most antimalarial drug samples will be collected in the province of Moyen-Ogooue. Study design: (Non-clinical) - Prospective observational drug-quality field survey.
- Main changes (audit trail)
- RECORD30-dec-2013 - 20-mrt-2016


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