Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria

Falciparum Malaria Clinical Trial

— ASPF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115439
• Other study ID #: BAKMAL1002
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: July 11, 2012
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Afghanistan: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria
• Malaria, Falciparum

Intervention

Drug:
• artesunate plus sulfadoxine-pyrimethamine (AS+SP)
artesunate plus sulfadoxine-pyrimethamine (AS+SP)

Locations

Country	Name	City	State
Afghanistan	Provincial Malaria Control Centers (MRC)	Asadabad	Kunar
Afghanistan	Provincial Malaria Control Centers (MRC)	Jalalabad	Nangarhar
Afghanistan	Provincial Malaria Control Centers (MRC)	Maimana	Faryab
Afghanistan	Provincial Malaria Control Centers (MRC)	Taloqan

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	National Malaria and Leishmaniasis Control Program, Afghanistan, World Health Organization

Country where clinical trial is conducted

Afghanistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing therapeutic failure	Proportion of patients experiencing therapeutic failure	42 days	No