NCT01464125

Brief Summary

The aim of this study is to evaluate the role of azithromycin as a possible combination partner for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
2 years until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 3, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

October 26, 2009

Last Update Submit

October 31, 2011

Conditions

Malaria

Keywords

MalariaPlasmodium falciparumacute uncomplicated

Outcome Measures

Primary Outcomes (3)

  • day 28 cure rate of >95%

    Efficacy of fosmidomycin and azithromycin when co-administered to adults with acute uncomplicated P.falciparum malaria. Day 7 cure rate and Day 28 cure rates will be calculated from the following ratio: Number of subjects with clearance of asexual parasitaemia within seven days of commencement of treatment, without subsequent recrudescence within 28 days divided by total number of evaluable subjects.

    12 months

  • Safety and Tolerance

    To determine the safety and tolerance of fosmidomycin and azothromycin when co-administered orally over three days. Safety and tolerability will be evaluated by the incidence, intensity, seriousness and relationship of new adverse event(s), and clinically relevant laboratory changes. The drug will be considered as safe if there are no serious adverse events attributable to the study drug.

    12 months

  • Day 7 cure rate of 100%

    Efficacy of fosmidomycin and azithromycin when co-administered to adults with acute uncomplicated P.falciparum malaria. Day 7 cure rate and Day 28 cure rates will be calculated from the following ratio: Number of subjects with clearance of asexual parasitaemia within seven days of commencement of treatment, without subsequent recrudescence within 28 days divided by total number of evaluable subjects.

    12 months

Secondary Outcomes (2)

  • Blood samples at 0,1,2,3,4,6,8,12,14,18,24, 26,30,36,38,42,48,50,54,60,62,66,72,78,84,90,96,108,120,144.168.240 hours

    12 months

  • PCR corrected cure rates

    12 months

Study Arms (1)

Fos-Azi

EXPERIMENTAL

Open label single arm concurrent administration of fosmidomycin and azithromycin.

Drug: FosmidomycinDrug: Azithromycin

Interventions

FosmidomycinDRUG

Fosmidomycin sodium capsules 450 mg x 4 twelve-hourly for three days

Fos-Azi
AzithromycinDRUG

Azithromycin capsules 250 mg x 3 twelve-hourly for three days

Fos-Azi

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male and female subjects aged 15 to 55 years
  • body mass index ≥ 18.5kg/M2
  • uncomplicated P falciparum malaria with acute manifestations
  • asexual parasitaemia between 500uL and 100,000uL
  • ability to tolerate oral therapy
  • able to give informed signed consent

You may not qualify if:

  • signs of severe malaria, according to WHO criteria
  • body mass index ≤ 18.5 kg/M2
  • pregnancy by history or by positive urine test
  • lactation
  • mixed plasmodial infection
  • concomitant disease masking assessment of response, including diabetes, uncontrolled hypertension, heart failure, hepatic dysfunction (alanine-amino transferase \> 150 U/L), renal impairment (creatinine \> 125 umol/L or 3 mg/dl), haemoglobin \< 8g/dl, white cell count \> 12000/uL
  • anti-malarial treatment within previous 28 days
  • symptomatic AIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

fosmidomycinAzithromycin

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Srivicha Krudsood, Prof

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

November 3, 2011

Study Start

November 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2011

Last Updated

November 3, 2011

Record last verified: 2011-10

Locations

TH(1)