Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria
Information source: University of Oxford
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Falciparum Malaria
Intervention: artesunate plus sulfadoxine-pyrimethamine (AS+SP) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Oxford Official(s) and/or principal investigator(s):
Ghulam Rahim Awab, MD, Principal Investigator, Affiliation: Mahidol Oxford Research Unit
Summary
In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium
falciparum resistance to chloroquine (80%) and more recently an increasing degree of
resistance to sulfadoxine-pyrimethamine monotherapy (12%). In 2003 the high failure rate of
chloroquine against falciparum malaria led the national malaria treatment programme to
switch its recommended first line drug treatment for uncomplicated Plasmodium falciparum
malaria to artemisinin-based combination therapy (ACT) in the form of
Artesunate/Sulfadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7
days). The aim of this study is to conduct ongoing monitoring of the efficacy of the new
combination against P. falciparum in a group of sentinel sites in Afghanistan.
Clinical Details
Official title: Efficacy and Safety of Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Centers in Nangarhar, Kunar, Thakhar and Faryab Provinces of Afghanistan
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Proportion of patients experiencing therapeutic failure
Detailed description:
The objective of the study is to assess the efficacy and safety of
Artesunate/Sulfadoxine-Pyrimethamine (AS+SP) for the treatment of uncomplicated P.
falciparum infections in Nangarhar, Kunar, Thakhar, Faryab malaria control centers in
Afghanistan.
This is an observational study. Patients will receive the recommended treatment for P.
falciparum malaria in Afghanistan (Nangarhar, Kunar, Thakhar, Faryab malaria control
centers). The participants will be febrile children above six months of age and non-pregnant
adults with confirmed uncomplicated P. falciparum infection. Patients will be treated with
AS+SP according to standard dosing regimens. Clinical and parasitological parameters will be
monitored over a 42-day follow-up period to evaluate drug efficacy. The study will be
conducted during the transmission season of falciparum malaria, i. e. October 2009 to January
2010 and September-December, 2010. Patients will be assessed clinically and via laboratory
tests, particularly focussing on whether recurrences are recrudescences of the original
infection or reinfections. All bio-medical findings will be recorded in specific patient
case record forms and the electronic form of analyzed data as well as a final report will be
sent to WHO-Afghanistan and National malaria control program offices for further actions.
The patients will receive reasonable transportation costs for follow-up visits as well as
one insecticide treated bed-net at the end of enrolment. The results of this study will be
used to assist the Ministry of Health of Afghanistan in assessing the current national
treatment guidelines for uncomplicated P. falciparum malaria.
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion:
- Age over six months.
- Mono-infection with P. falciparum detected by microscopy at a level of 500-150,000/µL
asexual forms
- Presence of axillary or tympanic temperature ≥ 37. 5 °C or oral or rectal temperature
of ≥ 38 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- ability and willingness to comply with the study protocol for the duration of the
study and to comply with the study visit schedule; and
- Informed consent from the patient or from a parent or guardian in the case of
children under 18 years of age.
Exclusion criteria:
- Presence of general danger signs in children aged under 5 years or signs of severe
falciparum malaria according to the definitions of the World Health Organization
(WHO)
- Mixed or mono-infection with another Plasmodium species detected by microscopy
- Presence of severe malnutrition (defined as a child whose growth standard is below -3
z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm
circumference < 110 mm)
- Presence of febrile conditions due to diseases other than malaria (e. g. measles,
acute lower respiratory tract infection, severe diarrhoea with dehydration) or other
known underlying chronic or severe diseases (e. g. cardiac, renal and hepatic
diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics;
- History of hypersensitivity reactions or contraindications to any of the study
medications;
- Female over 12 years of age
Locations and Contacts
Provincial Malaria Control Centers (MRC), Taloqan, Afghanistan
Provincial Malaria Control Centers (MRC), Maimana, Faryab, Afghanistan
Provincial Malaria Control Centers (MRC), Asadabad, Kunar, Afghanistan
Provincial Malaria Control Centers (MRC), Jalalabad, Nangarhar, Afghanistan
Additional Information
Starting date: March 2010
Last updated: July 11, 2012
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