SPK Study in Afghanistan

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01707199
• Date of registration: 11/10/2012
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: SPK Study in Afghanistan
• Scientific title: Efficacy and Safety of Artesunate+Sulphadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Center Asadabad in Kunar Province of Afghanistan
• Date of first enrolment: October 2012
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01707199
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Afghanistan

Contacts

• Name: Ghulam Rahim Awab, MD
• Affiliation: Research Dept. Ministry of Public Health (MoPH) Afghanistan

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;



Age minimum: 4 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Uncomplicated P. Falciparum Malaria

Intervention(s)

Drug: Artesunate + Sulphadoxine-pyrimethamine

Primary Outcome(s)

Adequate clinical and parasitological response (ACPR) [Time Frame: 42 days]

Secondary Outcome(s)

Molecular markers for antimalarial drug resistance [Time Frame: Baseline]

Adverse events [Time Frame: 42 days]

Secondary ID(s)

SPK

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

World Health Organization