Have Malaria Infections in Kenya Become Less Responsive to Artemisinin Treatment?

NCT01190371 | Unknown Phase 4

• 2 other identifiers: KEMRI_CT_2010/0013SSC 1821
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether P. falciparum infections in Kilifi District have developed tolerance to the artemisinin class of drugs.

Conditions

Malaria

Keywords

Artemisinin tolerance

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study will be the re-infection-adjusted day 28 failure rate

  Cure is defined as clearance of asexual P. falciparum parasitemia until day 7 and no recrudescence of asexual P. falciparum parasitemia until day 28. Re-infections are defined by genetic fingerprinting methods as newly emerging parasite clones during follow-up.

  Day 0-28

Secondary Outcomes (5)

• The proportion of patients with positive malaria smears

  24hr, 48hr, 72hr

• The percentage reduction of parasitaemia from baseline

  24hr, 48hr, 72hr

• The mean time to parasite clearance

  Up to day 7

• The mean time to fever clearance

  Up to day 7

• To estimate the rates for late clinical and parasitological failure rates

  Days 28 and 42

Study Arms (1)

Artesunate

OTHER

Confirmation of artemisinin tolerance

Drug: Artesunate

Interventions

Artesunate DRUG

Oral, once daily, 7-day regimen of artesunate 2mg/kg/day

Artesunate

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged between 6 months to 10 years, inclusive
• mono-infection with P. falciparum detected by microscopy;
• parasitaemia of 10,000-300,000/µl asexual forms;
• presence of axillary temperature ≥ 37.5 °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 a parent or guardian.

You may not qualify if:

• presence of clinical danger signs: not able to drink or breast-feed, vomiting (\>twice in 24 hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
• mixed or mono-infection with another Plasmodium species detected by microscopy;
• presence of severe acute malnutrition defined as weight for height \<70% of the median NCHS/WHO (Appendix 2);
• 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 or pharmacodynamic assessments (e.g., antibiotics with known antimalarial activity); and
• history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program: lead
• University of Oxford: collaborator
• Heidelberg University: collaborator

Study Sites (3)

Kadzinuni Dispensary

Kadzinuni, Kilifi County, Kenya

Location

Junju Dispensary

Kilifi, Kenya

Location

Pingilikani Dispensary

Kilifi, Kenya

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roma Chilengi

  KEMRI Centre for Geographic Medicine Research (Coast), University of Oxford, England

  PRINCIPAL INVESTIGATOR

• Steffen Borrmann

  KEMRI Centre for Geographic Medicine Research (Coast), Heidelberg University of Medicine, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 27, 2010
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2017-07

Locations

KE (3)