NCT00471666

Brief Summary

This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa. Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled. Participants undergo the following tests and procedures:

  • Baseline evaluation with medical history and physical examination, blood tests and stool culture
  • Brief physical examinations weekly
  • Blood tests monthly for malaria
  • Standard treatment offered for anyone with malaria
  • Blood tests for filarial infection at the beginning, midpoint and end of the transmission season
  • Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans.
  • Treatment for other parasitic worm infections, if needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,039

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2012

Completed
Last Updated

July 2, 2017

Status Verified

January 31, 2012

First QC Date

May 9, 2007

Last Update Submit

June 30, 2017

Conditions

MalariaFilariasis

Keywords

MalariaFilariasisCoinfectionCo-Infection

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 1 - 20 years
  • Male or non-pregnant female
  • Resident of Tien gu bougou or Bougoudiana

You may not qualify if:

  • History or clinical evidence of severe and/or chronic illness
  • History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
  • Plans to relocate outside the immediate vicinity of the village during the study period
  • Age 1 - 20 years
  • Male or non-pregnant female
  • Resident of Tien gu bougou or Bougoudiana
  • History or clinical evidence of severe and/or chronic illness
  • History of allergy to artesunate, amodiaquine, albendazole, praziquantel or mebendazole
  • Plans to relocate outside the immediate vicinity of the village during the study period
  • Hemoglobin less than or equal to 8 g/dL
  • Symptoms of malaria with parasitemia greater than or equal to 100,000/microliters at enrollment
  • Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting
  • Age \> 10 years
  • Male or non-pregnant female (by history)
  • Resident of Tien gu bougou or Bougoudiana
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Pharmacy and Odonto-Stomatology (FMPOS)

Bamako, Mali

Location

Related Publications (3)

  • Marsh K, Kinyanjui S. Immune effector mechanisms in malaria. Parasite Immunol. 2006 Jan-Feb;28(1-2):51-60. doi: 10.1111/j.1365-3024.2006.00808.x.

    PMID: 16438676BACKGROUND

  • Breman JG, Egan A, Keusch GT. The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):iv-vii. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.

    PMID: 11425185BACKGROUND

  • Gupta S, Snow RW, Donnelly CA, Marsh K, Newbold C. Immunity to non-cerebral severe malaria is acquired after one or two infections. Nat Med. 1999 Mar;5(3):340-3. doi: 10.1038/6560.

    PMID: 10086393BACKGROUND

MeSH Terms

Conditions

MalariaFilariasisCoinfection

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasis

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 9, 2007

First Posted

May 10, 2007

Study Start

May 7, 2007

Study Completion

January 31, 2012

Last Updated

July 2, 2017

Record last verified: 2012-01-31

Locations

MA(1)