SPK Study in Afghanistan

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oxford
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01707199
First received: October 11, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Uncomplicated P. Falciparum Malaria
Drug: Artesunate + Sulphadoxine-pyrimethamine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Adequate clinical and parasitological response (ACPR) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    WHO defined ACPR


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    The incidence of any adverse event will be documented. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit.

  • Molecular markers for antimalarial drug resistance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To study polymorphisms in PfDHFR, PfDHPS and copy number of PfGCH1 which are considered as markers of resistance to Sulphadoxine-pyrimethamine (SP) components.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artesunate + Sulphadoxine-pyrimethamine

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

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707199

Contacts
Contact: Charlie Woodrow, MD charlie@tropmedres.ac

Locations
Afghanistan
Narang, Asadabad, Watapoor district health centres Recruiting
Kunar, Afghanistan
Contact: Ghulam Rahim Awab, MD       awabgr@yahoo.com   
Principal Investigator: Ghulam Rahim Awab, MD         
Sponsors and Collaborators
University of Oxford
World Health Organization
Investigators
Principal Investigator: Ghulam Rahim Awab, MD Research Dept. Ministry of Public Health (MoPH) Afghanistan
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01707199     History of Changes
Other Study ID Numbers: SPK
Study First Received: October 11, 2012
Last Updated: August 27, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
P. falciparum
Sulphadoxine-pyrimethamine
Artesunate
Artemisinin Combination Therapy (ACT)

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on July 23, 2014