SPK Study in Afghanistan

NCT01707199 | Completed

• 1 other identifier: SPK
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium falciparum resistance to chloroquine. 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/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7 days). For operational reasons, prior to recent studies (manuscript in preparation) there have been no molecular data on P. falciparum SP resistance markers from within the borders of Afghanistan. These studies have revealed early evidence of increasing SP resistance (resistance polymorphisms with double DHFR \& triple DHPS mutations). The aim of this study is to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the AS+SP combination in this province, along with molecular studies of isolates from recruited patients.

Conditions

Uncomplicated P. Falciparum Malaria

Keywords

P. falciparum; Sulphadoxine-pyrimethamine; Artesunate; Artemisinin Combination Therapy (ACT)

Outcome Measures

Primary Outcomes (1)

• Adequate clinical and parasitological response (ACPR)

  WHO defined ACPR

  42 days

Secondary Outcomes (2)

• Adverse events

  42 days

• Molecular markers for antimalarial drug resistance

  Baseline

Study Arms (1)

Artesunate + Sulphadoxine-pyrimethamine

EXPERIMENTAL

AS+SP will be administered according to the patient's age, based on a dose of 4mg artesunate/kg body weight once daily for 3 days plus SP at a dose of 25mg sulphadoxine/kg body weight single dose on the first day. One co-blister pack of Artecospe will be used per patient and obtained via WHO from Guilin Pharmaceutical Co. Ltd., Shanghai China, with appropriate expiry date.

Drug: Artesunate + Sulphadoxine-pyrimethamine

Interventions

Artesunate + Sulphadoxine-pyrimethamine DRUG

AS+SP will be administered according to the patient's age, based on a dose of 4mg artesunate/kg body weight once daily for 3 days plus SP at a dose of 25mg sulphadoxine/kg body weight single dose on the first day. One co-blister pack of Artecospe will be used per patient and obtained via WHO from Guilin Pharmaceutical Co. Ltd., Shanghai China, with appropriate expiry date.

Artesunate + Sulphadoxine-pyrimethamine

Eligibility Criteria

• Age: 4 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males: age over 4 months;
• Females: age 4 months - 11 years inclusive, or 18 years or older;
• 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 16 years of age.

You may not qualify if:

• Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
• Infection with another Plasmodium species detected by microscopy not mixed with falciparum;
• Females 18 years or older: a positive pregnancy test or absence of a negative pregnancy test when a pregnancy test is not possible for cultural reasons;
• Breastfeeding
• 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;

Sponsors & Collaborators

• University of Oxford: lead
• World Health Organization: collaborator

Study Sites (1)

Narang, Asadabad, Watapoor district health centres

Khāş Kunaṟ, Kunar, Afghanistan

Location

Related Publications (1)

• Awab GR, Imwong M, Pukrittayakamee S, Alim F, Hanpithakpong W, Tarning J, Dondorp AM, Day NP, White NJ, Woodrow CJ. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction. Malar J. 2016 Feb 25;15:121. doi: 10.1186/s12936-016-1167-z.

  PMID: 26917051 DERIVED

MeSH Terms

Interventions

Artesunate; fanasil, pyrimethamine drug combination

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Ghulam Rahim Awab, MD

  Research Dept. Ministry of Public Health (MoPH) Afghanistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AF (1)