NCT00133393

Brief Summary

The primary objectives of this study is to identify a safe, tolerable dose of pentoxifylline in children with cerebral malaria and to establish an acceptable pentoxifylline dosage regimen for use in multi center Phase II and Phase III studies.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2002

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
Last Updated

August 27, 2010

Status Verified

October 1, 2005

First QC Date

August 19, 2005

Last Update Submit

August 26, 2010

Conditions

Plasmodium Falciparum Malaria

Interventions

PentoxifyllineDRUG

Eligibility Criteria

Age9 Months - 96 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age greater than or equal to 9 months and less than or equal to 96 months. Informed consent granted by parents/guardians (Appendix I).
  • Has cerebral malaria defined as all of the following:
  • peripheral parasitemia with asexual forms of P. falciparum; inability to localize a painful stimulus 30 minutes after correcting hypoglycemia (blood glucose less than 2.2 mmol/l) in patients who present with hypoglycemia 30 minutes after cessation of convulsive activity in patients who are convulsing on admission; no neck stiffness; no clinical evidence of pneumonia (no rales, no decreased breath sounds, no bronchial breathing).

You may not qualify if:

  • Children with the following will not be enrolled in the study:
  • Hypotension: mean blood pressure less than 60 mmHg (mean blood pressure = diastolic blood pressure (mmHg) + 1/3 (systolic blood pressure
  • diastolic blood pressure)). Thrombocytopenia: platelet count less than 50 x 10(to the ninth power)/l. Spontaneous bleeding noted in mouth, throat, nares, rectum, or a venipuncture site following adequate pressure.
  • Hematocrit \< 20% OR hematocrit between 20-25% with parasitemia greater than 10%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI Centre for Geographic Medicine Research

Kilifi, Kenya

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

January 1, 2002

Study Completion

July 1, 2005

Last Updated

August 27, 2010

Record last verified: 2005-10

Locations

KE(1)