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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

Page last updated: August 23, 2015

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