NCT01132248

Brief Summary

Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

2 active sites

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 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

May 27, 2010

Last Update Submit

January 23, 2013

Conditions

Urinary Schistosomiasis

Keywords

schistosomiasis, schistosoma haematobium

Outcome Measures

Primary Outcomes (1)

  • Reduction of egg excretion

    Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp

    6 weeks after second IPTp

Secondary Outcomes (1)

  • Cure rate

    6 weeks after first and second IPTp

Study Arms (2)

Mefloquine

EXPERIMENTAL

15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose

Drug: Mefloquine

S/P

PLACEBO COMPARATOR

sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations

Drug: S/P

Interventions

MefloquineDRUG

15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose

Mefloquine
S/PDRUG

sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations

S/P

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women after first trimester and before 28th week of pregnancy
  • HIV negative
  • Egg excretion of Schistosoma haematobium (mean \>10 eggs per mL urine)
  • Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia)
  • Ability to comply with study protocol

You may not qualify if:

  • Allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Schweitzer Hospital

Lambaréné, Moyen-Ogooué Province, BP 115, Gabon

Location

Albert Schweitzer Hospital

Lambaréné, Gabon

Location

Related Publications (2)

  • Salam RA, Das JK, Bhutta ZA. Effect of mass deworming with antihelminthics for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD005547. doi: 10.1002/14651858.CD005547.pub4.

    PMID: 33998661DERIVED

  • Basra A, Mombo-Ngoma G, Melser MC, Diop DA, Wurbel H, Mackanga JR, Furstenau M, Zoleko RM, Adegnika AA, Gonzalez R, Menendez C, Kremsner PG, Ramharter M. Efficacy of mefloquine intermittent preventive treatment in pregnancy against Schistosoma haematobium infection in Gabon: a nested randomized controlled assessor-blinded clinical trial. Clin Infect Dis. 2013 Mar;56(6):e68-75. doi: 10.1093/cid/cis976. Epub 2012 Nov 21.

    PMID: 23175561DERIVED

MeSH Terms

Conditions

Schistosomiasis haematobia

Interventions

Mefloquine

Condition Hierarchy (Ancestors)

SchistosomiasisTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsUrinary Tract InfectionsVector Borne DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

QuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. PD

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

GA(2)