Condition category
Infections and Infestations
Date applied
23/02/2006
Date assigned
03/03/2006
Last edited
22/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nilima Kshirsagar

ORCID ID

Contact details

Dean
Professor and Head
Department of Clinical Pharmacology
Seth GS Medical College and KEM Hospital
Parel
A Donde Marg
Mumbai
400012
India
+91 (0)22 24131419
dcpkem@vsnl.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BQ vs PQ

Study hypothesis

To assess whether bulaquine has superior gametocytocidal activity versus primaquine for Plasmodium falciparum malaria

Ethics approval

Yes, protocol approved by the Ethics Committee of the Seth GS Medical College and KEM Hospital, Mumbai, India

Study design

Randomised, parallel group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Uncomplicated P. falciparum malaria

Intervention

Patients are randomised to receive either one of two gametocytocidal drugs: bulaquine 75 mg or primaquine 45 mg

Intervention type

Drug

Phase

Not Specified

Drug names

Bulaquine, primaquine

Primary outcome measures

Gametocytemia at days 8, 15, 22 and 29 of follow-up

Secondary outcome measures

Gametocyte viability at days 8, 15, 22 and 29

Overall trial start date

01/06/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged more than 16 years
2. Uncomplicated Plasmodium falciparum malaria
3. Gametocyte count more than 55 /ul within 72 hours of diagnosis, irrespective of asexual parasitemia
4. Willing to give written, informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

93

Participant exclusion criteria

1. Pregnancy
2. Lactation
3. Allergy to primaquine or bulaquine

4. Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
5. Co-infection with Plasmodium vivax

Recruitment start date

01/06/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

India

Trial participating centre

Dean, Professor and Head
Mumbai
400012
India

Sponsor information

Organisation

Indian Council of Medical Research

Sponsor details

Ansari Nagar
PO Box 4911
New Delhi
110029
India
+91 (0)11 26589336
icmrhqds@sansad.nic.in

Sponsor type

Government

Website

http://www.icmr.nic.in

Funders

Funder type

Government

Funder name

The project was undertaken as part of the Indian Council of Medical Research centre for Advanced Research in Clinical Pharmacology at the department of clinical pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, India

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

A randomized, parallel study of the safety and efficacy of 45 mg primaquine versus 75 mg bulaquine as gametocytocidal agents in adults with blood schizonticide-responsive uncomplicated falciparum malaria; Nithya J Gogtay Dr, Karuna D Kamtekar Miss, Sudeshna S Dalvi Prof, Sanjay S Mehta Dr, Arun R Chogle Dr, Umesh Aigal Dr and Nilima A Kshirsagar Prof; BMC Infectious Diseases 2006, 6:16.
http://www.biomedcentral.com/1471-2334/6/16

Publication citations

Additional files

Editorial Notes